| 1 |
NCT02506426 |
Unknown † |
Endoscopic Sinus Surgery for Refractory Chronic Sinusitis |
|
- Procedure: Endoscopic sinus surgery + Septoplasty
- Procedure: Septoplasty alone
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Disease specific-quality of life using the 22-item sinonasal outcome test (SNOT-22)
- Strength of Patient Blinding using a group selection scale
- Generic quality of life using the EQ-5D questionnaire
- (and 3 more...)
|
44 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02506426 |
REB15-0809 |
|
July 2015 |
July 2017 |
July 2018 |
July 23, 2015 |
July 23, 2015 |
|
- University of Calgary
Calgary, Alberta, Canada - University of Ottawa
Ottawa, Ontario, Canada
|
|
| 2 |
NCT01253577 |
Completed
Has Results |
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis |
|
- Device: Sinus Stent with drug coating
- Device: Non Coated Sinus Stent
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percentage of Sinuses Requiring Post-operative Intervention
- Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure
- Percentage of Sinuses That Developed Frank Polyposis
|
105 |
All |
18 Years and older (Adult, Older Adult) |
NCT01253577 |
P500-1009 |
ADVANCE II |
December 2009 |
October 2010 |
October 2010 |
December 3, 2010 |
June 22, 2015 |
April 13, 2015 |
- Central California ENT
Fresno, California, United States - Colorado ENT & Allergy
Colorado Springs, Colorado, United States - Northwestern University
Chicago, Illinois, United States - (and 8 more...)
|
|
| 3 |
NCT03358329 |
Active, not recruiting |
Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) |
- Chronic Sinusitis
- Nasal Polyposis
|
- Combination Product: S8 Sinus Implant
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT03358329 |
P500-0717 |
|
November 13, 2017 |
January 3, 2018 |
March 15, 2019 |
November 30, 2017 |
January 29, 2018 |
|
- Sacramento ENT
Sacramento, California, United States - Yale University School of Medicine
New Haven, Connecticut, United States - DuPage Medical Group
Naperville, Illinois, United States - (and 6 more...)
|
|
| 4 |
NCT02931604 |
Not yet recruiting |
Study Designed to Clinically Evaluate Sinus Wash Device Prototypes |
- Sinusitis
- Maxillary Sinusitis
|
- Device: SinuSafe Medical Device for Maxillary Sinus
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Adverse events
- Mucosal damage visual inspection
- Syringe visual inspection
- (and 8 more...)
|
50 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02931604 |
SNS001 |
|
January 2017 |
November 2019 |
January 2020 |
October 13, 2016 |
October 13, 2016 |
|
|
|
| 5 |
NCT02291549 |
Completed
Has Results |
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps |
- Chronic Sinusitis
- Nasal Polyposis
|
- Drug: S8 Sinus Implant
- Drug: Mometasone furoate nasal spray
- Procedure: Sham
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Nasal Obstruction/Congestion Score
- Bilateral Polyp Grade
- Percentage of Patients Indicated for Repeat Endoscopic Sinus Surgery (RESS)
- (and 3 more...)
|
300 |
All |
18 Years and older (Adult, Older Adult) |
NCT02291549 |
P500-1113 |
RESOLVE_II |
December 2014 |
October 2016 |
October 2016 |
November 14, 2014 |
August 15, 2018 |
July 9, 2018 |
- The University of Alabama Birmingham
Birmingham, Alabama, United States - Kaiser Permanente Orange County Irvine Medical Center
Irvine, California, United States - Sacramento Ear, Nose and Throat Surgical and Medical Group, Inc.
Sacramento, California, United States - (and 37 more...)
|
|
| 6 |
NCT02967731 |
Active, not recruiting |
480 Biomedical Sinus Drug Depot |
|
- Drug: 480 Mometasone Furoate Sinus Drug Depot
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Product related serious adverse events from baseline visit to 4 weeks post procedure
- Plasma Mometasone Furoate concentration level from pre-treatment to end of treatment
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT02967731 |
480MFSDD2016-001 |
|
June 6, 2017 |
February 2018 |
June 2018 |
November 18, 2016 |
January 3, 2018 |
|
- The Queen Elizabeth Hospital
Adelaide, Australia - Royal Brisbane and Women's Hospital
Brisbane, Australia - Monash Medical Center
Melbourne, Australia - University of Auckland
Auckland, New Zealand
|
|
| 7 |
NCT02266810 |
Completed
Has Results |
Safety and Efficacy of the Propel Mini and Propel Nova Steroid-Eluting Sinus Implant in Frontal Sinus |
|
- Device: PROPEL Mini Sinus Implant.
- Procedure: Sinus Surgery alone
- Device: Propel Nova Sinus Implant
|
Interventional
|
Phase 3 |
- Intersect ENT
- Advance Research Associates
|
Industry / Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Percent of Sinuses That Require Post-operative Interventions (Propel Mini Cohort)
- Percent of Sinuses That Require Post-operative Interventions (Propel Nova Cohort)
- Need for Post-operative Interventions (Propel Mini Cohort)
- (and 7 more...)
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT02266810 |
P500-0514 |
PROGRESS |
September 2014 |
April 2016 |
October 2016 |
October 17, 2014 |
August 15, 2018 |
October 6, 2017 |
- Sacramento Ear, Nose and Throat
Sacramento, California, United States - Breathe Clear Institute of Sinus and Allergy Relief
Torrance, California, United States - The Connecticut Center for Advanced ENT Care
Norwalk, Connecticut, United States - (and 7 more...)
|
|
| 8 |
NCT00912405 |
Completed
Has Results |
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis |
|
- Device: Steroid-Eluting Sinexus Intranasal Splint
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Safety as Determined by the Frequency of Serious Adverse Local Tissue Response (SALT)
- Device Placement Success Rate
- Assessment of Changes From Baseline in Intra-ocular Pressure and Lens Opacities
- Number of Sinuses With Significant Post-operative Adhesion Formation
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT00912405 |
P500-0209 |
|
March 2009 |
June 2009 |
December 2009 |
June 3, 2009 |
April 20, 2015 |
April 20, 2015 |
- Central California Ear, Nose Thraot
Fresno, California, United States
|
|
| 9 |
NCT00236652 |
Completed |
A Study Evaluating the Safety and Efficacy of Treating Sinus Infection With Levofloxacin 750 mg for 5 Days. |
|
|
Interventional
|
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- PriCara, Unit of Ortho-McNeil, Inc.
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Time to bacteriological eradication, defined as the complete eradication of original strain(s) from the sinus, by the 5th day of levofloxacin treatment.
- Efficacy: Clinical response on Day 5 and at the Post-Therapy Visit (Days 12-19); plasma and sinus aspirate concentrations on Days 2-4; levels of inflammatory mediators on Days 0-5. Safety: Adverse events, vital signs, and clinical laboratory tests.
|
18 |
All |
18 Years and older (Adult, Older Adult) |
NCT00236652 |
CR004678 |
|
November 2003 |
|
June 2005 |
October 12, 2005 |
June 10, 2011 |
|
|
|
| 10 |
NCT02900794 |
Recruiting |
Gold Laser Vs. Micro-Debriders for Functional Endoscopic Sinus Surgery |
|
- Device: Gold Laser
- Procedure: Microdebridement
|
Interventional
|
Not Applicable |
- Texas Tech University Health Sciences Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Total Chronic Sinusitis Survey (CSS) Score
- Rhinosinusitis Disability Index (RSDI) Score
- Number of Patients Reporting Use of Sinusitis Related Medications Post-Surgically (Medications include: Oral antibiotics, Oral steroids, Topical intranasal steroid sprays, Topical and Nasal Anti-histamines)
- (and 2 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT02900794 |
L16-117 |
|
October 2016 |
September 2018 |
December 2018 |
September 14, 2016 |
January 5, 2018 |
|
- Texas Tech University Health Sciences Center
Lubbock, Texas, United States
|
|
| 11 |
NCT02228720 |
Completed
Has Results |
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia |
|
- Device: Propel Nova Sinus Implant
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Device Feasibility
|
- Device Placement Success Rate
- Ostial Patency
- Adhesion/Scarring Grade 2 & 3
- (and 2 more...)
|
15 |
All |
18 Years and older (Adult, Older Adult) |
NCT02228720 |
P500-0414 |
EXCEED |
June 2014 |
October 2014 |
January 2015 |
August 29, 2014 |
August 4, 2017 |
August 4, 2017 |
- South Florida ENT Associates
Miami, Florida, United States - Ohio Sinus Institute
Dublin, Ohio, United States
|
|
| 12 |
NCT00543998 |
Completed |
Near Infrared Transillumination of the Paranasal Sinuses |
|
- Device: Optical Measurement transillumination
|
Observational
|
|
- University of California, Irvine
- Beckman Laser Institute University of California Irvine
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
33 |
All |
15 Years to 75 Years (Child, Adult, Older Adult) |
NCT00543998 |
NIH-LAMMP-2002-2672 |
|
May 2003 |
June 2005 |
June 2005 |
October 16, 2007 |
February 10, 2017 |
|
- Beckman Laser Institute Medical Cinic, University of California,Irvine
Irvine, California, United States - Otolaryngology Medical Clinic, University of California, Irvine
Irvine, California, United States
|
|
| 13 |
NCT01066416 |
Unknown † |
Effects of Endoscopic Sinus Surgery for Chronic Sinusitis on Asthma Control |
|
- Procedure: Endoscopic Sinus Surgery
- Other: medical therapy
|
Interventional
|
Not Applicable |
- NorthShore University HealthSystem Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT01066416 |
0001 |
|
July 2009 |
December 2015 |
December 2015 |
February 10, 2010 |
February 10, 2010 |
|
- Evanston Hospital
Evanston, Illinois, United States
|
|
| 14 |
NCT01612780 |
Completed |
Trans-Nasal Maxillary Multi-Sinus Balloon Dilation Study |
|
- Device: XprESS Multi-Sinus Dilation Tool
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Change in quality of life
- Rate of revision/additional sinus surgery
|
81 |
All |
18 Years and older (Adult, Older Adult) |
NCT01612780 |
2233-001 |
|
April 2012 |
October 2013 |
October 2013 |
June 6, 2012 |
May 22, 2014 |
|
- Entellus Medical
Plymouth, Minnesota, United States
|
|
| 15 |
NCT01685229 |
Completed |
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis |
|
- Device: Balloon sinus dilation
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in disease-specific patient-reported quality of life (QOL)
- Change in disease-specific patient-reported quality of life
- Change in disease-specific and general health-related quality of life
- (and 6 more...)
|
198 |
All |
19 Years and older (Adult, Older Adult) |
NCT01685229 |
CPR005028 |
MERLOT |
September 2012 |
April 2015 |
August 2015 |
September 14, 2012 |
August 28, 2015 |
|
- Denver, Colorado, United States
- Miami, Florida, United States
- Tampa Bay, Florida, United States
- (and 17 more...)
|
|
| 16 |
NCT00643409 |
Completed |
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults |
|
- Drug: azithromycin SR (Zithromax; compound: CP-62,993)
- Other: placebo
- Drug: levofloxacin
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- sponsor assessment of clinical response for the Clinical per Protocol population
- sponsor assessment of clinical response by baseline pathogen for the Bacteriological per Protocol population
- investigator assessment of clinical response for the Clinical per Protocol population
- (and 5 more...)
|
541 |
All |
18 Years and older (Adult, Older Adult) |
NCT00643409 |
A0661078 |
|
January 2003 |
|
February 2004 |
March 26, 2008 |
May 11, 2011 |
|
- Pfizer Investigational Site
Alabaster, Alabama, United States - Pfizer Investigational Site
Birmingham, Alabama, United States - Pfizer Investigational Site
Birmingham, Alabama, United States - (and 86 more...)
|
|
| 17 |
NCT01350193 |
Completed |
Manuka Honey Irrigation After Sinus Surgery |
|
- Device: Manuka Honey
- Other: Saline Irrigation
|
Interventional
|
Phase 1
Phase 2 |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Post-operative endoscopic appearance
- Post-Operative SNOT-22
- Post-operative bleeding
- Post-operative pain
|
78 |
All |
19 Years and older (Adult, Older Adult) |
NCT01350193 |
MHI-2011 |
|
June 2011 |
January 2013 |
April 2013 |
May 9, 2011 |
December 4, 2013 |
|
- ENT Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
|
|
| 18 |
NCT03336671 |
Recruiting |
Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children |
- Chronic Sinusitis
- Adenoid Disease - Chronic
|
- Procedure: Endoscopic Sinus surgery
- Procedure: Adenoidectomy
|
Interventional
|
Not Applicable |
- State University of New York - Upstate Medical University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SN-5 at one year post procedure
- Revision/Alternate procedure, endoscopic sinus surgery
- Antibiotic use after surgical procedure
- Complication Rate
|
60 |
All |
6 Years to 12 Years (Child) |
NCT03336671 |
1009628 |
|
July 1, 2017 |
July 1, 2020 |
July 1, 2020 |
November 8, 2017 |
April 27, 2018 |
|
- SUNY Upstate Medical University
Syracuse, New York, United States
|
|
| 19 |
NCT01525862 |
Completed |
XprESS Maxillary Balloon Dilation Study |
|
- Device: Sinus Balloon Dilation Tool
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT01525862 |
2091-001 |
|
December 2011 |
January 2013 |
January 2013 |
February 3, 2012 |
February 13, 2013 |
|
- Entellus Medical
Maple Grove, Minnesota, United States
|
|
| 20 |
NCT01732536 |
Completed
Has Results |
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps |
- Chronic Sinusitis
- Nasal Polyps
|
- Drug: S8 Sinus Implant
- Procedure: Sham procedure
- Drug: Mometasone furoate nasal spray
|
Interventional
|
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Nasal Obstruction/Congestion Score
- Bilateral Polyp Grade
- Ethmoid Sinus Obstruction
- (and 2 more...)
|
100 |
All |
18 Years and older (Adult, Older Adult) |
NCT01732536 |
P500-1012 |
RESOLVE |
January 2013 |
November 2013 |
May 2014 |
November 26, 2012 |
July 20, 2018 |
July 20, 2018 |
- California Sinus Centers
Atherton, California, United States - Cedars-Sinai Medical Center, Sinus Center of Excellence
Los Angeles, California, United States - Sacramento Ear, Nose and Throat
Sacramento, California, United States - (and 16 more...)
|
|
| 21 |
NCT02627794 |
Terminated
Has Results |
Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery |
|
- Device: Restora™ Steroid eluting spacer
- Device: Silastic Silicone Spacer
|
Interventional
|
Phase 3 |
- Cedars-Sinai Medical Center
|
Other |
- Intervention Model: Single Group Assignment
- Masking: Single (Participant)
- Primary Purpose: Prevention
|
- Incidence of Middle Meatal Synechiae After Endoscopic Sinus Surgery in Silastic and Restora Steroid Eluting Spacer.
- 90-day Sinonasal Mucosal Inflammation Assessment
- 35 and 90-day Intraocular Pressure (IOP) Assessment
- (and 5 more...)
|
3 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02627794 |
Pro00039737 |
|
December 2015 |
April 2016 |
April 2016 |
December 11, 2015 |
November 17, 2017 |
November 17, 2017 |
- Cedars Sinai Medical Center
Los Angeles, California, United States
|
|
| 22 |
NCT00236522 |
Completed |
A Comparison of the Safety and Efficacy of Two Different Regimens of Levofloxacin in the Treatment of Acute Bacterial Sinusitis(Sinus Infection) in Adults. |
|
|
Interventional
|
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- PriCara, Unit of Ortho-McNeil, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double
- Primary Purpose: Treatment
|
- Clinical success (resolution of patient signs and symptoms) at the post-therapy visit.
- Microbiologic response at the post-therapy visit and safety evaluations.
|
784 |
All |
18 Years and older (Adult, Older Adult) |
NCT00236522 |
CR002809 |
|
October 2002 |
|
April 2004 |
October 12, 2005 |
June 10, 2011 |
|
|
|
| 23 |
NCT02509663 |
Recruiting |
Treatment of Chronic Frontal Sinusitis by a Simple Technique Using Dilation Balloons |
|
- Procedure: Functional Endoscopic Sinus Surgery
- Procedure: Functional Endoscopic Sinus Surgery using rigide instrumentation
- Device: Sinuplasty balloon
- Device: Endoscope
|
Interventional
|
Not Applicable |
- University Hospital, Strasbourg, France
- Assistance Publique - Hôpitaux de Paris
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Other
|
- Cost-utility ratio
- Quality of the patient's life
- Risks associated with intervention
- Economic impact of the sinuplasty balloon
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT02509663 |
6190 |
SIBA |
June 15, 2018 |
December 14, 2021 |
December 14, 2021 |
July 28, 2015 |
July 13, 2018 |
|
- Service ORL et de Chirurgie Cervico-Faciale Hôpital Pellegrin
Bordeau, France - Service ORL et de Chirurgie Cervico-Faciale CHU Gabriel Montpied
Clermont-Ferrand, France - Service ORL, stomatologie et de Chirurgie Cervico-Faciale Centre Hospitalier Intercommunal de Créteil
Créteil, France - (and 6 more...)
|
|
| 24 |
NCT03066908 |
Suspended |
Sinopsys Lacrimal Stent Study for Patients With Chronic Sinusitis or CRS |
|
- Device: Sinopsys® Lacrimal Stent
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Zinreich CT Score
- SNOT-22 Score
|
66 |
All |
22 Years and older (Adult, Older Adult) |
NCT03066908 |
SLSUS05 |
CRS |
April 20, 2017 |
December 2018 |
December 2018 |
March 1, 2017 |
November 9, 2018 |
|
- Front Range ENT
Greeley, Colorado, United States - Ear, Nose & Throat Associates of South Florida
Boca Raton, Florida, United States - Kentuckiana Ear, Nose & Throat, PSC
Louisville, Kentucky, United States - (and 3 more...)
|
|
| 25 |
NCT01714687 |
Completed |
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET) |
- Recurrent Acute Rhinosinusitis
|
- Device: balloon sinus dilation
- Other: medical therapy
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in disease-specific patient-reported quality of life (QOL)
- Change in disease-specific patient-reported quality of life
- Change in disease-specific and general health-related quality of life
- (and 5 more...)
|
59 |
All |
19 Years and older (Adult, Older Adult) |
NCT01714687 |
CPR005030 |
CABERNET |
October 1, 2012 |
October 1, 2015 |
April 1, 2016 |
October 26, 2012 |
July 2, 2017 |
|
- Birmingham, Alabama, United States
- Atlanta, Georgia, United States
- Las Vegas, Nevada, United States
- (and 2 more...)
|
|
| 26 |
NCT01919411 |
Completed |
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial |
|
- Drug: Amoxicillin-Potassium Clavulanate
- Drug: Placebo
|
Interventional
|
Phase 4 |
- Massachusetts Eye and Ear Infirmary
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Sinonasal outcome test - 22
- Lund Kennedy Endoscopic Score
|
134 |
All |
18 Years and older (Adult, Older Adult) |
NCT01919411 |
11-053H |
|
February 2013 |
September 2018 |
September 2018 |
August 9, 2013 |
October 3, 2018 |
|
- Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
|
|
| 27 |
NCT00416182 |
Completed
Has Results |
Nasally Delivered Pulmozyme for Sinusitis in Cystic Fibrosis |
|
- Drug: Pulmozyme (dornase alfa)
- Drug: Placebo
|
Interventional
|
Phase 2 |
- University of Vermont
- Genentech, Inc.
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Investigator)
- Primary Purpose: Treatment
|
- Computed Tomography Evidence of Less Sinus Disease
- Improvement in Appearance of Nasal Passages/Sinuses
- Chronic Sinusitis Survey Score
- Pulmonary Function
|
16 |
All |
5 Years and older (Child, Adult, Older Adult) |
NCT00416182 |
Z3297S |
|
December 2006 |
June 2012 |
June 2012 |
December 27, 2006 |
November 14, 2014 |
November 14, 2014 |
- Fletcher Allen Health Care
Burlington, Vermont, United States
|
|
| 28 |
NCT00423176 |
Terminated
Has Results |
The Study of Nasonex® Compared With Placebo for the Relief of Symptoms Associated With Acute Bacterial Sinusitis When Used With Antibiotics (Study P04824AM3) |
|
- Drug: MFNS and antibiotic
- Drug: Matching Placebo nasal spray plus antibiotic
|
Interventional
|
Phase 3 |
- Merck Sharp & Dohme Corp.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Baseline Change in AM/PM PRIOR Major Symptoms Score (Mss) Minus Sinus Headache Averaged Over Days 1 to 29.
- Change From Baseline to Endpoint in Percent of Opacification of the Maxillary Sinus That Had the Maximum Opacification Score at Baseline
|
237 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00423176 |
P04824 |
|
December 2006 |
June 2008 |
June 2008 |
January 18, 2007 |
April 12, 2017 |
June 22, 2010 |
|
|
| 29 |
NCT02278484 |
Completed
Has Results |
Sinus Balloon Dilation in Pediatric Patients |
|
- Device: XprESS device and PathAssist confirmation tools
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Technical Success: Sinuses Successfully Treated With Balloon Dilation
- Complications
- Change in Quality of Life From Baseline Through Completion
- Number of Subjects Who Undergo a Revision or Additional Surgery During the Study
|
50 |
All |
2 Years to 21 Years (Child, Adult) |
NCT02278484 |
2827-001 |
|
September 2014 |
September 2015 |
January 2016 |
October 30, 2014 |
April 11, 2017 |
December 7, 2016 |
- North Valley ENT
Phoenix, Arizona, United States - Willamette ENT and Facial Plastic Surgery
Salem, Oregon, United States - Medical University of South Carolina
Charleston, South Carolina, United States - Alamo ENT and Associates
San Antonio, Texas, United States
|
|
| 30 |
NCT01894503 |
Completed
Has Results |
Safety and Performance of the Steroid-Releasing S8 Sinus Implant |
|
- Drug: S8 Sinus Implant (mometasone furoate, 1350 mcg)
|
Interventional
|
Phase 2 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Sinuses With Successful Implant Delivery
- Number of Patients With Plasma Mometasone Furoate Concentration >LLOQ
|
5 |
All |
18 Years and older (Adult, Older Adult) |
NCT01894503 |
P500-0513 |
S8PK |
June 2013 |
October 2013 |
October 2013 |
July 10, 2013 |
July 18, 2018 |
June 25, 2018 |
- Sacramento ENT
Sacramento, California, United States
|
|
| 31 |
NCT02071667 |
Withdrawn |
Association of Periostin Levels and Chronic Sinusitis |
|
|
Observational
|
|
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Difference in circulating serum periostin levels pre and post sinus surgery
|
0 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT02071667 |
17123 |
|
September 2014 |
September 2016 |
October 2016 |
February 26, 2014 |
May 4, 2017 |
|
- University of Virginia
Charlottesville, Virginia, United States
|
|
| 32 |
NCT03390257 |
Recruiting |
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD |
|
- Device: 3NT flexible endoscope
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Type, frequency and severity of Adverse device effects
- Ability to access and visualize the paranasal sinuses
- User satisfaction
|
15 |
All |
18 Years and older (Adult, Older Adult) |
NCT03390257 |
SD001 |
|
April 25, 2017 |
April 2018 |
July 2018 |
January 4, 2018 |
January 4, 2018 |
|
- SF Otolaryngology
San Francisco, California, United States - Ogden Clinic
Salt Lake City, Utah, United States
|
|
| 33 |
NCT01575223 |
Completed |
Saline Irrigation After Surgery in Patients With Chronic Sinusitis |
|
- Device: NeilMed sinus rinse
- Device: Salinex
|
Interventional
|
Phase 4 |
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- NeilMed Pharmaceuticals
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Treatment
|
- Sinonasal Outcomes Scale (SNOT-22)
- Lund MacKay score
- Nasal and Sinus Symptom Score (NSS) - Subjective scale
- Perioperative Sinus Endoscopy scale (POSE)
|
86 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01575223 |
HVSI-001 |
HVSI |
March 2012 |
April 2014 |
April 2014 |
April 11, 2012 |
April 23, 2014 |
|
- University of Calgary Otolaryngology - Head & Neck Surgery
Calgary, Alberta, Canada - Western University Dept. of Otolaryngology - Head & Neck Surgery
London, Ontario, Canada - Ottawa University Otolaryngology - Head & Neck Surgery
Ottawa, Ontario, Canada - Mount Sinai Hospital
Toronto, Ontario, Canada
|
|
| 34 |
NCT02975310 |
Recruiting |
In-clinic Endoscopic Polypectomy for Chronic Sinusitis With Nasal Polyps |
|
- Procedure: Endoscopic polypectomy in clinic (EPIC)
- Procedure: Endoscopic Sinus Surgery (ESS)
- Other: General Anesthesia
- Other: Local and topical anesthesia
|
Interventional
|
Not Applicable |
- Ottawa Hospital Research Institute
- Canadian Institutes of Health Research (CIHR)
- Medtronic
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sinonasal Outcome Test-22 (SNOT-22)
- Peak Nasal Inspiratory Flow (PNIF):
- Iowa Satisfaction with Anesthesia Scale (ISAS)
- (and 4 more...)
|
140 |
All |
18 Years and older (Adult, Older Adult) |
NCT02975310 |
CTO-0801 |
|
April 11, 2017 |
November 2018 |
April 2019 |
November 29, 2016 |
September 25, 2017 |
|
- Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
|
|
| 35 |
NCT00249210 |
Completed |
A Study of the Safety and Effectiveness of Levofloxacin Compared With Amoxicillin/Clavulanate Potassium in the Treatment of Adults With Rapid Onset of Severe Inflammation/Infection of the Sinuses |
- Sinusitis
- Maxillary Sinusitis
|
|
Interventional
|
Phase 3 |
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- PriCara, Unit of Ortho-McNeil, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Clinical response rate (a reduction in signs and symptoms, and stabilization/improvement of sinus x-ray results) at post-therapy visit, 2 - 5 days after the last dose of study drug
- Incidence of adverse events; change in physical examination, and laboratory tests from the start of the study to after treatment
|
614 |
All |
18 Years and older (Adult, Older Adult) |
NCT00249210 |
CR005485 |
|
August 1993 |
|
July 1994 |
November 7, 2005 |
June 10, 2011 |
|
|
|
| 36 |
NCT02880514 |
Completed
Has Results |
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia |
|
- Device: PROPEL Mini Sinus Implant
- Procedure: Balloon Sinus Dilation Alone
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Patency Rate
- Inflammation Score
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02880514 |
P500-0616 |
FRONTIER |
August 2016 |
December 2016 |
June 2017 |
August 26, 2016 |
December 10, 2018 |
December 10, 2018 |
- Sacramento ENT
Sacramento, California, United States - ENT Assoicates of South Florida
Boca Raton, Florida, United States - ENT of Georgia
Atlanta, Georgia, United States - (and 6 more...)
|
|
| 37 |
NCT00705237 |
Terminated |
Study of the Use of LUMA Lightwire |
|
- Procedure: Functional Endoscopic Sinus Surgery with Balloon Dilatation
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Time, ease and accuracy of placement - compare accuracy of trans-illumination with fluoroscopy
|
50 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT00705237 |
LCID 2007-118 |
|
March 2008 |
May 2008 |
February 2009 |
June 25, 2008 |
February 18, 2009 |
|
- Lahey Clinic
Burlington, Massachusetts, United States
|
|
| 38 |
NCT00231062 |
Completed
Has Results |
Clinical Evaluation to Confirm Safety and Efficacy of Sinuplasty in the Paranasal Sinuses (CLEAR) |
|
|
Interventional
|
Phase 3 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Sinuses With Patency of Sinus Ostium After Sinuplasty
- Number of Participants With Adverse Events Following Sinuplasty Procedure
- Number of Participants Experiencing Relief of Sinus Symptoms
|
115 |
All |
18 Years and older (Adult, Older Adult) |
NCT00231062 |
CP-00313 |
|
April 2005 |
June 2006 |
June 2006 |
October 4, 2005 |
July 8, 2011 |
July 8, 2011 |
|
|
| 39 |
NCT01107379 |
Completed
Has Results |
Optimization and Refinement of Technique in In-Office Sinus Dilation 2 |
|
- Device: Relieva Balloon Sinuplasty System
|
Observational
|
|
|
Industry |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Mean Intra-patient Change in SNOT-20 Score
- Mean Intra-patient Change in Lund-Mackay CT Scan Score
- Procedure Tolerability
- (and 3 more...)
|
203 |
All |
18 Years and older (Adult, Older Adult) |
NCT01107379 |
CPR005010 |
ORIOS 2 |
April 2010 |
January 2012 |
July 2012 |
April 21, 2010 |
September 18, 2014 |
September 18, 2014 |
- Birmingham, Alabama, United States
- Las Vegas, Nevada, United States
- Dublin, Ohio, United States
|
|
| 40 |
NCT02077322 |
Completed |
Rates of Middle Meatal Synechia Formation Following Functional Endoscopic Sinus Surgery |
|
- Device: Silastic Spacer
- Device: Merocel Spacer
|
Interventional
|
Not Applicable |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Prevention
|
- Incidence of middle meatal synechiae after functional endoscopic sinus surgery in silastic versus merocel groups.
- Incidence of postoperative synechiae in 6-day versus 14-day postoperative spacer removal groups.
|
48 |
All |
19 Years and older (Adult, Older Adult) |
NCT02077322 |
Synechiae-2014 |
SYNECHIAE |
March 2014 |
May 2017 |
May 2017 |
March 4, 2014 |
April 20, 2018 |
|
- St. Paul's Hospital Sinus Centre
Vancouver, British Columbia, Canada
|
|
| 41 |
NCT00939471 |
Completed
Has Results |
Safety and Efficacy of Balloon Sinuplasty in Pediatric Sinusitis |
|
- Device: Relieva™ Balloon Sinuplasty™ System
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Safety: Device-related Adverse Events During Balloon Dilation Through 12 Months
- Effectiveness: Change in Sinus Symptom Scores (SN-5)
- Effectiveness: Change in Sinus Symptom Scores (SNOT-20)
- (and 5 more...)
|
44 |
All |
2 Years to 17 Years (Child) |
NCT00939471 |
CPR01918 |
INTACT |
April 1, 2007 |
July 1, 2009 |
May 1, 2010 |
July 15, 2009 |
September 5, 2017 |
August 17, 2012 |
- West Virginia University
Morgantown, West Virginia, United States
|
|
| 42 |
NCT01485484 |
Suspended |
Development and Validation of a NIRS-based Sinusitis Screening |
|
- Device: Optic imaging use near-infrared trans-illumination methods
|
Observational
|
|
- University of California, Irvine
- Beckman Laser Institute University of California Irvine
|
Other |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
|
170 |
All |
18 Years and older (Adult, Older Adult) |
NCT01485484 |
NIH/LAMMP-2011-8295 |
|
September 2011 |
July 2018 |
July 2018 |
December 5, 2011 |
February 14, 2018 |
|
- UCI Beckman Laser Medical Clinic
Irvine, California, United States
|
|
| 43 |
NCT01455948 |
Terminated |
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis |
|
- Device: Relieva Balloon Sinuplasty™ System
- Procedure: Functional Endoscopic Sinus Surgery
|
Interventional
|
Phase 4 |
- Johnson & Johnson Medical Companies
- Acclarent
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Health Services Research
|
- The direct and indirect costs of treatment of frontal and other sinus disease with Functional Endoscopic Sinus Surgery or balloon sinuplasty.
- Health outcome of patients in the two treatment groups.
- Effectiveness of the two treatment groups in relieving symptomology of CRS.
|
25 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT01455948 |
JJMC-001 |
CHEC |
February 2012 |
November 2012 |
November 2012 |
October 20, 2011 |
September 2, 2015 |
|
- Hamilton General Hospital
Hamilton, Ontario, Canada - St. Joseph's Health Centre
London, Ontario, Canada - Ottawa Hospital - Civic Campus
Ottawa, Ontario, Canada - (and 5 more...)
|
|
| 44 |
NCT01054703 |
Terminated
Has Results |
Clinical Evaluation of the Ethmoid Sinus Spacer |
- Sinusitis, Chronic Rhinosinusitis
|
- Device: Ethmoid Sinus Spacer
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Occurrence of Adverse Events at the Time of the Procedure and Cumulatively up to 6 Weeks Post-implant
- Efficacy: Improvement in Ethmoid Sinus Health as Demonstrated by CT Scan and Quality-of-life Measures
|
14 |
All |
21 Years and older (Adult, Older Adult) |
NCT01054703 |
CPR02082 |
SPACER |
April 1, 2007 |
November 1, 2007 |
November 1, 2007 |
January 22, 2010 |
August 7, 2017 |
February 24, 2010 |
- Georgia Nasal and Sinus Institute
Savannah, Georgia, United States
|
|
| 45 |
NCT02981017 |
Recruiting |
Improvement of Outcomes in Draf III/Endoscopic Modified Lothrop Procedure |
- Chronic Sinusitis
- Frontal Sinusitis
|
- Device: Porcine Intestinal submucosal xenograft
|
Interventional
|
Not Applicable |
- University of California, Los Angeles
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Frontal sinus stenosis
- Number of postoperative debridements
- Need for further surgical intervention
- (and 3 more...)
|
50 |
All |
18 Years and older (Adult, Older Adult) |
NCT02981017 |
16-001257 |
|
November 2016 |
December 2019 |
December 2019 |
December 2, 2016 |
February 12, 2018 |
|
- University of California Los Angeles
Los Angeles, California, United States
|
|
| 46 |
NCT02548598 |
Recruiting |
Analysis of Inflammation and Microbiome in Patients With Sinusitis and Asthma |
- Asthma
- Chronic Rhinosinusitis
|
- Procedure: Endoscopic sinus surgery
|
Observational
|
|
- University of California, San Francisco
|
Other |
- Observational Model: Cohort
- Time Perspective: Cross-Sectional
|
- Severity of chronic rhinosinusitis as assessed by the Sino-Nasal Outcome Test-22
|
160 |
All |
18 Years and older (Adult, Older Adult) |
NCT02548598 |
14-14945 |
AIMS |
January 2017 |
September 2018 |
December 2018 |
September 14, 2015 |
February 24, 2017 |
|
- UCSF Airway Clinical Research Center
San Francisco, California, United States
|
|
| 47 |
NCT02463279 |
Completed |
SinuSys Patency of Frontal Recess and Sphenoid Sinus Ostia Study |
|
- Device: Sinusys Dilation System
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Patency of treated target site
- Reports of sinus related adverse events during the 3 months follow-up period
|
30 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT02463279 |
SNS-006 |
|
April 2015 |
October 2015 |
March 2016 |
June 4, 2015 |
December 13, 2016 |
|
- Upland ENT
Upland, California, United States - Colorado ENT
Denver, Colorado, United States - St. Elizabeth Medical Center
Brighton, Massachusetts, United States
|
|
| 48 |
NCT00335309 |
Completed |
Maxillary Sinus Irrigation in the Management of Chronic Rhinosinusitis |
|
- Procedure: Maxillary Sinus Irrigation
- Drug: IV Amoxicillin and Clavulanate acid
|
Interventional
|
Not Applicable |
- Ohad Ronen
- Carmel Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- CT Scoring
- Quality of life Questionaire
- Nasal Endoscopy score
|
50 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00335309 |
ENT-1/2005
20051031 |
|
October 2005 |
August 2013 |
August 2013 |
June 9, 2006 |
October 8, 2013 |
|
|
|
| 49 |
NCT00534768 |
Completed |
Postoperative Treatment After Endoscopic Sinus Surgery |
|
- Procedure: active debridement
- Procedure: control group
|
Interventional
|
Not Applicable |
- Kuopio University Hospital
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- scarring in middle meatus 4 weeks after ESS
|
|
All |
18 Years to 70 Years (Adult, Older Adult) |
NCT00534768 |
KUH5551813 |
|
January 2003 |
|
|
September 26, 2007 |
January 14, 2008 |
|
- Kuopio University Hospital
Kuopio, Finland
|
|
| 50 |
NCT00000752 |
Withdrawn |
Preventing Frequent Sinus Infections in HIV-Infected Patients |
|
- Drug: Pseudoephedrine hydrochloride
- Drug: Guaifenesin
- Drug: Cefuroxime axetil
- Drug: Beclomethasone dipropionate
|
Interventional
|
Phase 2 |
- National Institute of Allergy and Infectious Diseases (NIAID)
- Adams Laboratories
- Glaxo Wellcome
|
NIH / Industry |
- Masking: Double
- Primary Purpose: Treatment
|
|
0 |
All |
12 Years and older (Child, Adult, Older Adult) |
NCT00000752 |
ACTG 186 |
|
|
|
February 1993 |
August 31, 2001 |
May 18, 2015 |
|
- Univ of California / San Diego Treatment Ctr
San Diego, California, United States - Stanford at Kaiser / Kaiser Permanente Med Ctr
San Francisco, California, United States - Montefiore Drug Treatment Ctr / Bronx Municipal Hosp
Bronx, New York, United States - (and 7 more...)
|
|
| 51 |
NCT02687438 |
Completed |
The PIO (Propel In Office) III Study of In-office Placement of a Steroid-Eluting Implant Immediately Following Ethmoid Sinus Surgery |
|
- Device: Steroid-releasing sinus implant
- Other: Post-op standard of care
|
Interventional
|
Not Applicable |
- ENT and Allergy Associates, LLP
- Intersect ENT
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- the change from baseline to day 90 in nasal obstruction / congestion score
- the change from baseline to day 90 in bilateral polyp grade
- Ethmoid Sinus Obstruction
- (and 9 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT02687438 |
PIO III |
|
December 2015 |
February 2016 |
February 2016 |
February 22, 2016 |
November 17, 2016 |
|
- ENT and Allergy Associates, LLP
Lake Success, New York, United States - ENT and Allergy Associates, LLP
New York, New York, United States - ENT and Allergy Associates, LLP
Port Jefferson, New York, United States - ENT and Allergy Associates, LLP
White Plains, New York, United States
|
|
| 52 |
NCT01825408 |
Completed
Has Results |
Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis |
|
- Drug: Doxycycline
- Drug: Azithromycin
- Drug: Augmentin
|
Interventional
|
Phase 4 |
- University of North Carolina, Chapel Hill
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Patients Recommended for Sinus Surgery After 3 Weeks of Antibiotic Therapy
- Number of Patients Recommended for Sinus Surgery After 6 Weeks of Antibiotic Therapy
|
40 |
All |
18 Years to 99 Years (Adult, Older Adult) |
NCT01825408 |
12-2377 |
|
February 2013 |
June 2014 |
June 2014 |
April 5, 2013 |
April 4, 2017 |
April 4, 2017 |
- Department of Otolaryngology-Head and Neck Surgery clinics at UNC Hospitals
Chapel Hill, North Carolina, United States
|
|
| 53 |
NCT01525849 |
Completed
Has Results |
Randomized Evaluation of Maxillary Antrostomy Versus Ostial Dilation Efficacy Through Long-Term Follow-Up |
|
- Device: Balloon Sinus Dilation
- Procedure: Functional Endoscopic Sinus Surgery
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sinus Symptom Improvement
- Debridements
- Revision Rate
- (and 2 more...)
|
151 |
All |
18 Years and older (Adult, Older Adult) |
NCT01525849 |
1984-001 |
REMODEL |
December 2011 |
February 2014 |
May 2014 |
February 3, 2012 |
February 24, 2017 |
February 24, 2017 |
- Entellus Medical
Plymouth, Minnesota, United States
|
|
| 54 |
NCT02668302 |
Completed
Has Results |
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant |
- Chronic Sinusitis, Ethmoidal
|
- Combination Product: Steroid-eluting sinus implant
- Other: Post-op standard of care
|
Interventional
|
Phase 4 |
- Collin County Ear Nose & Throat
- Intersect ENT
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02668302 |
P2015-09 |
|
November 2015 |
November 2016 |
November 2016 |
January 29, 2016 |
October 12, 2018 |
October 12, 2018 |
- Collin County Ear Nose & Throat
Frisco, Texas, United States
|
|
| 55 |
NCT01623050 |
Completed
Has Results |
Safety and Performance of the SinuSys Dilation System for Dilation of the Maxillary Sinus Ostium |
|
- Device: SinuSys Dilation System
|
Interventional
|
Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Patency of Treated Area
- Number of Participants With Device-related Adverse Events as a Measure of Safety
|
36 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT01623050 |
SNS-005 |
|
April 2012 |
June 2013 |
September 2014 |
June 19, 2012 |
November 5, 2014 |
October 1, 2014 |
- Valley ENT
Tucson, Arizona, United States - Palo Alto Medical Foundation
Palo Alto, California, United States - St. Elizabeth Medical Center
Boston, Massachusetts, United States - (and 2 more...)
|
|
| 56 |
NCT02812199 |
Recruiting |
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications |
|
- Device: Composite Removable Sinus Stent
- Drug: adrenaline-lidocaine
- Procedure: cold saline wash
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Composite Removable Sinus Stent efficacy compared to standard of care
- Pain associated with Composite Stent removal vs. standard of care removal
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT02812199 |
461001P |
|
August 2016 |
December 2017 |
December 2017 |
June 24, 2016 |
May 2, 2017 |
|
- Herzliya Medical Center
Herzliya, Israel
|
|
| 57 |
NCT00140608 |
Terminated |
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery |
|
- Device: Seprapack Sinus Dressing
|
Interventional
|
Not Applicable |
- Genzyme, a Sanofi Company
- Sanofi
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single
- Primary Purpose: Treatment
|
- reduction in post-operative scarring when compared to use of no sinus packing
|
|
All |
18 Years and older (Adult, Older Adult) |
NCT00140608 |
SPACK00104ORP |
|
June 2003 |
|
May 2005 |
September 1, 2005 |
March 18, 2015 |
|
- Medical University of South Carolina
Charleston, North Carolina, United States - University of Cincinnati College of Medicine
Cincinnati, Ohio, United States - UT Health Science Center
Memphis, Tennessee, United States
|
|
| 58 |
NCT00939393 |
Completed
Has Results |
Balloon Sinus Dilation In Office or OR |
|
- Device: FESS instruments with or without balloon treatment
- Device: Balloon Sinuplasty
|
Interventional
|
Not Applicable |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Health Services Research
|
- Mean Intra-patient Change in SNOT-20 Score at 24 Weeks Post-procedure Compared to Baseline
- Mean Intra-patient Change in Lund-MacKay CT Score [24 Weeks]
- Proportion of Participants Rating Procedure as Tolerable (IO Only)
- (and 7 more...)
|
72 |
All |
18 Years and older (Adult, Older Adult) |
NCT00939393 |
CPR005002 |
ORIOS |
April 1, 2008 |
June 1, 2009 |
July 1, 2010 |
July 15, 2009 |
October 23, 2017 |
October 3, 2014 |
- Rockside Road Surgery Center
Independence, Ohio, United States
|
|
| 59 |
NCT00683371 |
Active, not recruiting |
Microarray Analysis of Sinus Samples From Patients With and Without Chronic Rhinosinusitis |
|
- Procedure: Specimen collection
|
Interventional
|
Not Applicable |
- University of California, San Francisco
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Investigator)
- Primary Purpose: Diagnostic
|
- Microbial community profiling using the PhyloChip, MycoChip, and ViroChip will yield vast quantities of data to be reduced in dimensions for interpretation. Pathogens detected in the nasal mucus of patients with CRS will be compared to healthy controls.
- The presence or absence of a given microorganism will be compared to previously published data obtained using either traditional culture methods or other genomic methods.
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT00683371 |
H43796-31316-03 |
|
October 2007 |
September 2018 |
September 2018 |
May 23, 2008 |
November 1, 2017 |
|
- University of California, San Francisco, Dept of Otolaryngology-HNS
San Francisco, California, United States
|
|
| 60 |
NCT02502084 |
Completed |
Safety and Effectiveness Evaluation of the Sinusway Device for Endoscopy of the Nasal Cavity and Paranasal Sinuses |
|
- Device: 3NT flexible endoscope
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Safety assessed by unanticipated device-related adverse events
- Performance assessed by anatomical landmarks reached and visualized will be recorded
|
17 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT02502084 |
3NT-IL1 |
|
August 2015 |
April 2017 |
June 2017 |
July 20, 2015 |
December 22, 2017 |
|
- Ghent University
Ghent, Belgium - Assuta Medical Center
Tel Aviv, Israel
|
|
| 61 |
NCT00852410 |
Unknown † |
The Hemostatic and Hemodynamic Effects of Adrenaline During Endoscopic Sinus Surgery |
|
- Drug: 1% lidocaine with 1:100,000 adrenaline
- Drug: 1% lidocaine with 1:200,000 adrenaline
|
Interventional
|
Phase 3 |
|
Other |
- Allocation: Randomized
- Intervention Model: Single Group Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Reduction of Intraoperative bleeding
- hemodynamic fluctuation
|
140 |
All |
18 Years to 80 Years (Adult, Older Adult) |
NCT00852410 |
09-0001-A |
|
March 2009 |
April 2010 |
April 2010 |
February 27, 2009 |
June 30, 2010 |
|
- University of Toronto
Toronto, Ontario, Canada
|
|
| 62 |
NCT00626366 |
Completed |
Distribution of Topical Nasal Medication Within the Nasal Cavity and Sinuses by Radiographic Comparison |
|
- Radiation: Sinus CT Scan
- Drug: Omnipaque 240 Contrast Solution
- Drug: Omnipaque 240 mg I/mL
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Other
|
- To determine the distribution of nasal sprays and drops.
|
9 |
All |
19 Years and older (Adult, Older Adult) |
NCT00626366 |
498-07-FB |
|
March 2008 |
January 2009 |
January 2009 |
February 29, 2008 |
August 23, 2018 |
|
- ENT Specialist PC of Omaha
Omaha, Nebraska, United States
|
|
| 63 |
NCT00671541 |
Withdrawn |
Nasospore Stent For Use in Enodscopic Sinus Surgery |
|
- Drug: Merogel Nasal Stent and Nasopore Stent
- Drug: Nasopore Stent and either Gentamycin or Bacitracin
|
Interventional
|
Phase 4 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- This study will evaluate the efficacy of nasopore stent soaked in bacitracin in and one stent soaked in gentaymcin antibiotic solution
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT00671541 |
LCID 2006-026 |
|
March 2006 |
February 2012 |
February 2012 |
May 5, 2008 |
February 17, 2012 |
|
- Lahey Clinic, Inc
Burlington, Massachusetts, United States
|
|
| 64 |
NCT02297243 |
Completed |
Sinopsys Lacrimal Stent Indicated for Sinus Irrigation |
|
- Device: Sinopsys Lacrimal Stent
|
Interventional
|
Early Phase 1 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SNOT - 20
- Patency will be confirmed post procedure with passive flow through the SLS lumen by instilling 2-4 drops of sterile saline into the stented medial fornix and observing drainage.
- Safety: Incidence and occurrence of anticipated and unanticipated adverse events
- (and 2 more...)
|
9 |
All |
22 Years and older (Adult, Older Adult) |
NCT02297243 |
SLS-US-02 |
SLS |
March 2015 |
February 2016 |
February 2016 |
November 21, 2014 |
February 12, 2016 |
|
- Stanford University
Stanford, California, United States - Front Range ENT
Greeley, Colorado, United States - Advanced ENT and Allergy
Louisville, Kentucky, United States
|
|
| 65 |
NCT02221128 |
Completed |
PerClot to Control Bleeding in Endoscopic Sinus Surgery |
|
|
Observational
|
|
- CryoLife Europa
- CryoLife, Inc.
|
Industry |
- Observational Model: Case-Only
- Time Perspective: Prospective
|
- Number of subjects who achieve of haemostasis after the application of PerClot
- Number of subjects who require the use of alternative methods to achieve haemostasis after the application of PerClot
|
12 |
All |
18 Years and older (Adult, Older Adult) |
NCT02221128 |
PCT1402.001M(06/14) |
|
July 2014 |
September 2014 |
September 2014 |
August 20, 2014 |
October 3, 2014 |
|
- Guys and St Thomas NHS Trust
London, United Kingdom
|
|
| 66 |
NCT03766568 |
Not yet recruiting
New |
Single Use Device Endoscopy for the Diagnosis of Acute Bacterial Rhinosinusitis in Primary Care |
- Acute Bacterial Sinusitis
|
|
Interventional
|
Not Applicable |
- Dominik Glinz
- University Hospital, Basel, Switzerland
- Basel Institute for Clinical Epidemiology and Biostatistics
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Diagnostic
|
- Prevalence of successful JGG endoscope® application
- Prevalence of complications
- Influence of JGG endoscope® to support the decision of antibiotic prescribing
- (and 6 more...)
|
60 |
All |
18 Years and older (Adult, Older Adult) |
NCT03766568 |
Sinus-Endo Study |
Sinus-Endo |
December 17, 2018 |
May 31, 2019 |
September 30, 2019 |
December 6, 2018 |
December 6, 2018 |
|
|
|
| 67 |
NCT00705354 |
Withdrawn |
Pilot Study To Evaluate A Pharmacologically Active Nasal Sponge Following Endoscopic Sinus Surgery |
- Sinusitis
- Chronic Sinusitis
|
- Drug: Bacitracin
- Procedure: Nasopore sponge soaked with saline
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- The two groups of subjects will be compared on clincal & demographic characteristics. Evaluation of any new infection (no or yes).
- Clinical and demographic data will be evaluate presence/absence of inflammation of surrounding, adhesions, pain, granulation tissue
|
0 |
All |
18 Years and older (Adult, Older Adult) |
NCT00705354 |
2007-119 |
|
January 2009 |
October 2010 |
October 2010 |
June 26, 2008 |
April 13, 2012 |
|
- Lahey Clinic, Inc.
Burlington, Massachusetts, United States
|
|
| 68 |
NCT03250429 |
Active, not recruiting |
Nasal and Peripheral Blood Biomarkers of CRS Patients Before and After Surgical Intervention |
|
|
Observational
|
|
- University of North Carolina, Chapel Hill
- Flight Attendant Medical Research Institute
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Change in Inflammatory mediators in the nasal mucosa
- Change in Inflammatory mediators in the peripheral blood
- Change in Rhinosinusitis Disability Index (RSDI) Scores
- (and 2 more...)
|
30 |
All |
18 Years to 64 Years (Adult) |
NCT03250429 |
17-1499 |
|
September 1, 2017 |
December 2018 |
December 2018 |
August 15, 2017 |
October 12, 2018 |
|
- Center for Environmental Medicine, Asthma and Lung Biology
Chapel Hill, North Carolina, United States
|
|
| 69 |
NCT00799097 |
Completed |
Determinants of Surgical Outcomes in Chronic Sinusitis |
|
|
Observational
|
|
- Oregon Health and Science University
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease specific quality of life
- General quality of life
- Olfactory function
|
516 |
All |
18 Years and older (Adult, Older Adult) |
NCT00799097 |
R01 DC0005805
R01DC005805 |
|
July 2004 |
June 2009 |
December 2009 |
November 27, 2008 |
May 20, 2010 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
|
| 70 |
NCT01706952 |
Completed
Has Results |
Comparison of Topical Vasoconstriction in Endoscopic Sinus Surgery |
|
- Drug: Cocaine
- Drug: Adrenaline
|
Interventional
|
Phase 4 |
- Marc Tewfik
- McGill University Health Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Care Provider)
- Primary Purpose: Other
|
- To Estimate the Change in Bleeding Category (Surgical Field Improvement) as Measured on a Six-point Scale, Measured From 0 (Best Case) to 5 (Worst Case).
- Heart Rate
- Blood Pressure
- End Tidal CO2
|
45 |
All |
18 Years and older (Adult, Older Adult) |
NCT01706952 |
12-251-SDR |
|
December 2012 |
December 2013 |
December 2013 |
October 15, 2012 |
May 3, 2017 |
May 3, 2017 |
- Department of Otolaryngology-Head and Neck Surgery. McGill University Health Center
Montreal, Quebec, Canada
|
|
| 71 |
NCT03304951 |
Completed |
Sinopsys® Lacrimal Stent Indicated for Sinus Irrigation |
|
- Device: Sinopsys® Lacrimal Stent
|
Interventional
|
Not Applicable |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Demonstration of acute procedural/device success
- Evaluation of Clinical Success at Week 1, 4 and 8 weeks
- Compare performance of Screening, 4, and 8 week follow up Modified Lund Kennedy nasal endoscopy scores
|
8 |
All |
22 Years and older (Adult, Older Adult) |
NCT03304951 |
SLSEU01 |
|
April 2016 |
August 2016 |
August 2016 |
October 9, 2017 |
September 6, 2018 |
|
- Charles University Faculty of Medicine
Pilsen, Czechia
|
|
| 72 |
NCT00747747 |
Completed
Has Results |
Sinuclean's Treatment Of Sinusitis' Symptoms |
|
- Biological: Saline solution
- Device: Sinuclean DM Spray
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Presence of Mucus in the Paranasal Sinuses (Outcome Measure Percentage of Patients)
- FACIAL PAIN Daily Retrospective Ranking of Symptoms as Assessed by the Subject
- Recovery of Sinusitis Per Clinical Assessment(Outcome Measure Percentage of Patients)
- Recovery of Sinusitis Per Clinical Assessment (Outcome Measure Percentage of Patients)
|
49 |
All |
18 Years and older (Adult, Older Adult) |
NCT00747747 |
GAL-01-2007
EudraCT: 2007-003739-22 |
SToSS |
November 2007 |
January 2009 |
February 2010 |
September 5, 2008 |
March 14, 2012 |
March 14, 2012 |
- University Cattolica del Sacro Cuore
Rome, Lazio, Italy
|
|
| 73 |
NCT02079792 |
Completed |
The Optimal Head Position for Distributing Topical Nasal Medication Using the Mucosal Atomization Device |
|
- Procedure: Lying Head Back Position
- Procedure: Head Down and Forward Position
|
Interventional
|
Phase 4 |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- Endoscopic sinonasal mucosal inflammation
- Quality of Life (via SNOT-22)
|
66 |
All |
19 Years and older (Adult, Older Adult) |
NCT02079792 |
HeadPositionMAD2014 |
Head Position |
June 2014 |
June 2015 |
August 2015 |
March 6, 2014 |
April 14, 2016 |
|
- St. Paul's Hospital Sinus Centre
Vancouver, British Columbia, Canada
|
|
| 74 |
NCT01255566 |
Completed |
Medical Therapy Versus Sinus Surgery for Chronic Rhinosinusitis: A Prospective, Multi-institutional Study |
- Chronic Rhinosinusitis
- Sinusitis
|
|
Observational
|
|
- Oregon Health and Science University
- Medical University of South Carolina
- Northwestern University
- University of Pennsylvania
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Rhinosinusitis Disability Index and Chronic Sinusitis Survey
|
186 |
All |
18 Years and older (Adult, Older Adult) |
NCT01255566 |
unfunded |
|
August 2009 |
July 2012 |
August 2012 |
December 7, 2010 |
April 24, 2013 |
|
- Northwestern University
Chicago, Illinois, United States - University of Pennsylvania
Philadelphia, Pennsylvania, United States - Medical University of South Carolina
Charleston, South Carolina, United States
|
|
| 75 |
NCT03729310 |
Recruiting |
Comparison of Two Steroid Nasal Implants Following Endoscopic Sinus Surgery for Chronic Rhinosinusitis |
- Chronic Sinusitis
- Rhinosinusitis
|
- Device: Propel 'implant'
- Drug: Triamcinolone
- Device: Nasopore
|
Interventional
|
Early Phase 1 |
- Weill Medical College of Cornell University
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change from Pre-operative score in Patient's nasal endoscopy, as measured by Perioperative Sinus Endoscopy (POSE) Scores
- Change from Pre-operative score in Patient's nasal endoscopy, as measured by the Lund-Kennedy Endoscopic Score.
- Change from Pre-operative score in Patient's sinonasal quality of life, as measured by SNOT-22 (Sino-nasal outcome test)
|
24 |
All |
18 Years to 100 Years (Adult, Older Adult) |
NCT03729310 |
1802018943 |
|
February 1, 2019 |
September 24, 2019 |
February 5, 2020 |
November 2, 2018 |
December 6, 2018 |
|
- Teresa Valderrama
New York, New York, United States
|
|
| 76 |
NCT03661346 |
Completed |
Esmolol vs. Labetalol in Endoscopic Sinus Surgery |
|
- Drug: Labetalol
- Drug: Esmolol
|
Interventional
|
Phase 2 |
- The University of Texas Medical Branch, Galveston
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Intra-operative surgical visibility - Boezaart scale
- Intra-operative surgical visibility - Wormald scale
- Rate of blood loss
- (and 2 more...)
|
38 |
All |
18 Years and older (Adult, Older Adult) |
NCT03661346 |
15-0309 |
|
March 1, 2017 |
March 30, 2018 |
March 30, 2018 |
September 7, 2018 |
September 7, 2018 |
|
- University of Texas Medical Branch
Galveston, Texas, United States
|
|
| 77 |
NCT00242437 |
Completed |
Hemostatic Matrix in Endoscopic Sinus Surgery |
|
- Device: Hemostatic matrix
- Device: bovine thrombin
|
Interventional
|
Phase 4 |
|
Industry |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Educational/Counseling/Training
|
- Success in achieving hemostasis after product application
- Post operative healing
- Patient Satisfaction
- Time to hemostasis
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT00242437 |
400-05-002 |
|
October 2005 |
|
February 2006 |
October 20, 2005 |
July 13, 2006 |
|
- The Summit Medical GroupDepartment of Otolaryngology
Summit, New Jersey, United States - The Medical University of South Carolina Department of Otolaryngology
Charleston, South Carolina, United States - University of Tennessee Department of Otolaryngology
Memphis, Tennessee, United States
|
|
| 78 |
NCT02533206 |
Active, not recruiting |
Pilot Study of The EPIC Trial |
|
- Procedure: Endoscopic Polypectomy Performed in Clinic
- Procedure: Functional Endoscopic Sinus Surgery (FESS)
|
Interventional
|
Not Applicable |
- Ottawa Hospital Research Institute
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Rate of recruitment
- Arm cross-over
- Loss to follow up
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT02533206 |
20150487-01H |
|
August 2015 |
June 2020 |
June 2020 |
August 26, 2015 |
September 25, 2017 |
|
- Royal Victoria Hospital
Barrie, Ontario, Canada - St Joseph's Health Care
London, Ontario, Canada - The Ottawa Hospital
Ottawa, Ontario, Canada - (and 2 more...)
|
|
| 79 |
NCT00671281 |
Withdrawn |
The Effect of Tranexamic Acid on Intraoperative and Post-Operative Bleeding in Functional Endoscopic Sinus Surgery |
|
- Drug: Tranexamic acid
- Drug: Placebo
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Primary Purpose: Treatment
|
- Intraoperative bleeding amount
- Surgical visualization scoring
- Postoperative bleeding events
|
74 |
All |
18 Years to 65 Years (Adult, Older Adult) |
NCT00671281 |
Tranexamic Acid in FESS |
|
October 2008 |
June 2009 |
December 2009 |
May 5, 2008 |
September 3, 2010 |
|
- Rockyview General Hospital
Calgary, Alberta, Canada
|
|
| 80 |
NCT01332136 |
Completed |
Determinants of Medical and Surgical Treatment Outcomes in Chronic Sinusitis |
|
|
Observational
|
|
- Oregon Health and Science University
- National Institute on Deafness and Other Communication Disorders (NIDCD)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Disease-specific quality of life
- General health-related quality-of-life
- Olfaction
|
966 |
All |
18 Years to 90 Years (Adult, Older Adult) |
NCT01332136 |
2R01DC005805 |
|
April 2011 |
March 2016 |
March 2016 |
April 8, 2011 |
March 29, 2016 |
|
- Oregon Health & Science University
Portland, Oregon, United States
|
|
| 81 |
NCT03068728 |
Completed |
Analysis of Hemostatic Agents Compared to Physiologic Hemostasis |
|
- Device: Arista
- Device: Nexafoam
- Device: Sinufoam
- (and 3 more...)
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of participants with superior healing qualities after use of hemostatic agents compared to physiologic hemostasis after endoscopic sinus surgery.
|
55 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03068728 |
24331 |
|
May 13, 2014 |
April 10, 2017 |
April 10, 2017 |
March 3, 2017 |
February 28, 2018 |
|
|
|
| 82 |
NCT02311140 |
Unknown † |
Effects of Kalydeco on Upper Airway and Paranasal Sinus Inflammation Measured by Nasal Lavage and on Symptoms |
- Inflammatory Changes in Epithelial Lining Fluid Sampled Non-invasively by Nasal Lavage in CF Patients With G551D Receiving Kalydeco
|
- Other: nasal lavage (routine diagnostic procedure in our centre), assessment of symptoms
|
Observational
|
|
- University of Jena
- University of Innsbruck, Austria
|
Other |
- Observational Model: Cohort
- Time Perspective: Prospective
|
- Changes in concentration of inflammatory markers
|
10 |
All |
6 Years and older (Child, Adult, Older Adult) |
NCT02311140 |
UKJ-IVA-Nasal |
KPNSI |
July 2012 |
September 2017 |
January 2018 |
December 8, 2014 |
October 25, 2016 |
|
- Jena University Hospital, CF Center
Jena, Germany
|
|
| 83 |
NCT01420471 |
Completed |
Medicated Punctured-Glove-Finger Spacer Study |
|
- Drug: Triamcinolone
- Other: Saline-impregnated spacer
|
Interventional
|
Phase 4 |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Post-operative endoscopic appearance
- Post-operative inflammation
- Post-Operative SNOT-22
|
50 |
All |
19 Years and older (Adult, Older Adult) |
NCT01420471 |
FISHNET-2011 |
FISHNET |
September 2011 |
May 2012 |
June 2012 |
August 19, 2011 |
October 30, 2012 |
|
- E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
|
|
| 84 |
NCT01990820 |
Completed |
Study for the Management of Pediatric Chronic Rhinosinusitis With or Without Balloon Sinuplasty |
- Rhinitis + Sinusitis, Pediatric Chronic Rhinosinusitis
|
- Device: Acclarent Relieva Balloon Sinuplasty
- Procedure: Adenoidectomy + Maxillary Sinus Irrigation
|
Interventional
|
Not Applicable |
- NorthShore University HealthSystem Research Institute
- NorthShore University HealthSystem
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Quality of life (QoL) outcomes between Adenoidectomy + Maxillary sinus irrigation with or without the use of balloon dilation or maxillary sinus ostia.
|
25 |
All |
2 Years to 12 Years (Child) |
NCT01990820 |
EH09-177 |
|
March 2009 |
September 29, 2016 |
September 29, 2016 |
November 21, 2013 |
August 29, 2017 |
|
- NorthShore University HealthSystem
Evanston, Illinois, United States
|
|
| 85 |
NCT00554190 |
Completed
Has Results |
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel |
- Ethmoid Sinusitis
- Rhinosinusitis
|
- Device: AdvaCoat sinus gel
- Device: Merogel Injectable
|
Interventional
|
Phase 4 |
- Carbylan Therapeutics, Inc.
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Number of Participants With Adhesion as Measured by the Synechia (Adhesion) Scale
- Number of Participants With Solicited and Recorded Adverse Events
|
29 |
All |
18 Years to 85 Years (Adult, Older Adult) |
NCT00554190 |
ACOT 1.0 |
|
May 2007 |
December 2007 |
December 2007 |
November 6, 2007 |
April 23, 2009 |
April 23, 2009 |
- Alabama Nasal & Sinus Center
Birmingham, Alabama, United States - University of California, San Francisco, Dept of Otolaryngology
San Francisco, California, United States - Northwestern University Medical Center, Department of Otolaryngology
Chicago, Illinois, United States - Cleveland Nasal Sinus & Sleep
Cleveland, Ohio, United States
|
|
| 86 |
NCT03369717 |
Not yet recruiting |
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery |
|
|
Interventional
|
Phase 4 |
- Montefiore Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Prevention
|
- Decrease in postoperative infection
- Improvement in postoperative endoscopy scores
- Improvement in postoperative SNOT-22 scores
|
400 |
All |
18 Years and older (Adult, Older Adult) |
NCT03369717 |
2017-8460 |
|
April 2018 |
January 2019 |
July 2019 |
December 12, 2017 |
March 21, 2018 |
|
|
|
| 87 |
NCT03454607 |
Recruiting |
Foot Controlled Robotic Endoscope Enabled Robot FESS |
- Sinusitis
- Polyp of Nasal Sinus
|
|
Interventional
|
Not Applicable |
- Chinese University of Hong Kong
|
Other |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Other
|
- Conversion
- Perioperative complications
- Surgical outcomes
- (and 2 more...)
|
20 |
All |
18 Years and older (Adult, Older Adult) |
NCT03454607 |
CRE-2017.307-T |
|
January 4, 2018 |
October 31, 2018 |
November 30, 2018 |
March 6, 2018 |
March 6, 2018 |
|
- The Chinese University of Hong Kong
Shatin, Hong Kong
|
|
| 88 |
NCT03036735 |
Terminated
Has Results |
Rates of Middle Meatus Synechiae Formation Post ESS |
|
- Device: steroid eluting spacer
|
Interventional
|
Not Applicable |
- Steward St. Elizabeth's Medical Center of Boston, Inc.
- SinuSys Corporation
|
Other / Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Number of Participants With Incidence of Middle Meatal Synechiae Post Fess ( Functional Endoscopic Surgery )," as Accurate and Appropriate).
|
10 |
All |
18 Years to 75 Years (Adult, Older Adult) |
NCT03036735 |
00723 |
|
April 5, 2015 |
April 5, 2016 |
December 2016 |
January 30, 2017 |
October 19, 2018 |
October 19, 2018 |
|
|
| 89 |
NCT01608308 |
Completed
Has Results |
Intraoperative and Post-operative Analgesic Effect of IV Acetaminophen for Sinus Surgery |
|
- Drug: IV Acetaminophen
- Drug: Placebo
|
Interventional
|
Not Applicable |
- The University of Texas Health Science Center, Houston
- Mallinckrodt
|
Other / Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- Pain Level Assessed Using a Visual Analogue Scale (VAS) Scale
- Total Doses of Postoperative Opiate (Morphine) Use
- Number of Participants Who Received Intraoperative Supplemental Fentanyl
- (and 6 more...)
|
62 |
All |
18 Years to 68 Years (Adult, Older Adult) |
NCT01608308 |
HSC-MS-12-0111 |
IVAPAP |
July 2012 |
September 2014 |
September 2014 |
May 31, 2012 |
October 16, 2015 |
September 4, 2015 |
- The University of Texas Health Sciences Center at Houston
Houston, Texas, United States
|
|
| 90 |
NCT01442740 |
Completed |
15-Degree Tilt, Head Up, Feet Down Body Position for Sinus Surgery Patients |
|
- Procedure: Reverse Trendelenburg Position
|
Interventional
|
Not Applicable |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Supportive Care
|
- Boezaart intra-operative surgical field scale
- Intra-operative vital signs
|
64 |
All |
19 Years and older (Adult, Older Adult) |
NCT01442740 |
RTP-2011 |
RTP |
October 2011 |
March 2012 |
May 2012 |
September 28, 2011 |
August 30, 2013 |
|
- E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
|
|
| 91 |
NCT02194062 |
Completed
Has Results |
Comparison of Nasal Steroids After FESS in CRSwNP |
|
- Drug: fluticasone nasal spray
- Drug: Budesonide head upright
- Drug: Budesonide head forward
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- SNOT-22 Scores
- Lund-Kennedy Scoring for Nasal Endoscopy
|
32 |
All |
18 Years and older (Adult, Older Adult) |
NCT02194062 |
1407014259 |
|
January 2015 |
July 2015 |
August 2015 |
July 18, 2014 |
February 8, 2018 |
March 16, 2017 |
- Yale Physicians Bldg
New Haven, Connecticut, United States - Yale ENT Stratford
Stratford, Connecticut, United States
|
|
| 92 |
NCT01717274 |
Completed |
Hot Saline Irrigation Study |
|
- Procedure: Hot saline irrigation
|
Interventional
|
Not Applicable |
- St. Paul's Hospital, Canada
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Investigator, Outcomes Assessor)
- Primary Purpose: Supportive Care
|
- The Boezaart and van der Merwe intraoperative surgical field scale
- Total Estimated Blood Loss
|
60 |
All |
19 Years to 75 Years (Adult, Older Adult) |
NCT01717274 |
HSI-2012 |
HSI |
November 2012 |
March 2015 |
April 2015 |
October 30, 2012 |
April 14, 2016 |
|
- E.N.T. Clinic, St. Paul's Hospital
Vancouver, British Columbia, Canada
|
|
| 93 |
NCT01111669 |
Completed |
Intravenous Tranexamic Acid and Intraoperative Visualization During Functional Endoscopic Sinus Surgery |
- Chronic Rhinosinusitis With Polyposis
- Chronic Hyperplastic Sinusitis
|
- Drug: Tranexamic Acid
- Drug: Normal Saline (placebo)
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- The Wormald grading scale, this is a validated instrument used to assess intraoperative bleeding during video endoscopy sinus surgery.
- Perioperative Sinus Endoscopy (POSE) scoring system, a systematic visualization evaluation of the sinuses
- Surgical time.
- (and 3 more...)
|
28 |
All |
17 Years and older (Child, Adult, Older Adult) |
NCT01111669 |
200901 |
|
August 2009 |
December 2011 |
December 2011 |
April 27, 2010 |
April 27, 2012 |
|
- University of Alberta Hospital, Royal Alexandra Hospital
Edmonton, Alberta, Canada
|
|
| 94 |
NCT01564355 |
Completed |
Postoperative Systemic Corticosteroids When Utilizing a Steroid-Eluting Spacer Following Endoscopic Sinus Surgery |
- Chronic Sinusitis
- Endoscopic Sinus Surgery
- Post-operative Care
- (and 2 more...)
|
- Device: Steroid-eluting middle meatal spacer (Nasopore (TM) spacer impregnated with 1 cc of 40mg/mL triamcinolone liquid)
- Drug: Post-op Oral Steroids
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Health Related Quality of Life Score (based on SNOT-22, VAS, and RSDI questionnaires)
- Sinus mucosal disease endoscopic grading score (based on Lund-Kennedy and POSE Scoring systems)
|
80 |
All |
18 Years and older (Adult, Older Adult) |
NCT01564355 |
24336 |
|
April 2012 |
September 2013 |
December 2013 |
March 27, 2012 |
December 3, 2014 |
|
- Richmond Road Diagnostic and Treatment Centre
Calgary, Alberta, Canada
|
|
| 95 |
NCT00924404 |
Completed
Has Results |
Xylitol Versus Saline in Chronic Sinusitis |
|
- Drug: Xylitol
- Drug: Saline
|
Interventional
|
Not Applicable |
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Outcomes Assessor)
- Primary Purpose: Treatment
|
- SNOT-20 Scores at 12 Weeks
- Mean Number of Antibiotic Courses During the Study Period
|
53 |
All |
18 Years and older (Adult, Older Adult) |
NCT00924404 |
200903757 |
|
May 2009 |
August 2014 |
August 2014 |
June 19, 2009 |
August 31, 2018 |
August 9, 2017 |
- University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
|
|
| 96 |
NCT00232154 |
Completed |
A Study To Measure The Level Of Drug In Nasal Tissue And Blood After Taking A Single 2g Dose Or 500mg Tablets For Up To |
|
- Drug: Zithromax™ (azithromycin) 500mg tablets
- Procedure: Endoscopic Sinus Surgery
- Procedure: Blood sampling for hematology
- (and 2 more...)
|
Interventional
|
Phase 2 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: None (Open Label)
|
- To characterize the pharmacokinetics of azithromycin in sinus mucosal tissue and plasma in adult subjects after treatment with a single 2 g oral dose of azithromycin extended release for oral suspension or oral azithromycin 500 mg tablet
- To assess the safety of azithromycin extended release for oral suspension and azithromycin 500mg tablets.
|
72 |
All |
18 Years and older (Adult, Older Adult) |
NCT00232154 |
A0661151 |
|
November 2005 |
June 2006 |
June 2006 |
October 4, 2005 |
April 21, 2011 |
|
- Pfizer Investigational Site
Alabaster, Alabama, United States - Pfizer Investigational Site
Birmingham, Alabama, United States - Pfizer Investigational Site
Birmingham, Alabama, United States - (and 15 more...)
|
|
| 97 |
NCT02562924 |
Completed |
The Efficacy of MEDIHONEY® for Chronic Rhinosinusitis With Nasal Polyposis After Functional Endoscopic Sinus Surgery |
- Chronic Sinusitis
- Nasal Polyposis
|
- Device: MEDIHONEY®
- Drug: Budesonide
- Drug: Normal saline sinus rinse
- (and 3 more...)
|
Interventional
|
Not Applicable |
- University of Vermont Medical Center
|
Other |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Investigator, Outcomes Assessor)
- Primary Purpose: Treatment
|
- Lund-Kennedy endoscopic scores
- Nasal drainage cultures
- SNOT-22 questionnaire
- Symptom scores
|
40 |
All |
18 Years and older (Adult, Older Adult) |
NCT02562924 |
CHRMS 15-010 |
|
November 2015 |
December 2017 |
December 2017 |
September 29, 2015 |
January 17, 2018 |
|
- University of Vermont Medical Center
Burlington, Vermont, United States
|
|
| 98 |
NCT03154541 |
Completed |
SynRinse Irrigation Pilot (SIP) Trial |
- Sinusitis, Chronic
- Cystic Fibrosis With Other Manifestations
|
|
Interventional
|
Phase 1
Phase 2 |
|
Other |
- Allocation: Non-Randomized
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Sino-Nasal Outcome Test 22 (SNOT-22)
- Sinus bacteria culture
- Lund-Kennedy Endoscopy Score (LKES)
- (and 2 more...)
|
30 |
All |
18 Years and older (Adult, Older Adult) |
NCT03154541 |
STUDY00001280 |
|
June 6, 2017 |
May 30, 2018 |
May 30, 2018 |
May 16, 2017 |
October 17, 2018 |
|
- University of Washington
Seattle, Washington, United States
|
|
| 99 |
NCT00791934 |
Completed
Has Results |
Clinical Study of Safety and Efficacy for the Relieva Stratus With Elution of Triamcinolone Acetonide |
|
- Device: Stratus Microflow Ethmoid Spacer
|
Interventional
|
Phase 3 |
|
Industry |
- Intervention Model: Single Group Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
|
- Mean Intrapatient Change in Ethmoid Lund-MacKay CT Score (Ethmoid Score Only) at 10 Weeks Post-procedure Compared to Baseline.
- Number of Participants With Decrease in Vision Greater Than 2 Lines Per Snellen Chart (BCVA at Baseline vs. BCVA 10 Week Post-procedure)
- Number of Participants With Either a Change in Intraocular Pressure (IOP) ≥10mmHg OR Documented IOP > 21 mmHg
- Mean Intra-patient Change in SNOT-20 Score Post-procedure Compared to Baseline
|
63 |
All |
17 Years and older (Child, Adult, Older Adult) |
NCT00791934 |
CPR005003 |
DELIVER |
August 2008 |
November 2011 |
November 2011 |
November 17, 2008 |
July 25, 2014 |
July 14, 2014 |
- Lahey Clinic
Burlington, Massachusetts, United States
|
|
| 100 |
NCT00962689 |
Completed |
Clinical Study to Improve Diagnosis and Treatment of Sinusitis |
|
|
Observational
|
|
- Ohio State University
- National Institutes of Health (NIH)
- National Center for Research Resources (NCRR)
|
Other / NIH |
- Observational Model: Cohort
- Time Perspective: Prospective
|
|
38 |
All |
5 Years to 90 Years (Child, Adult, Older Adult) |
NCT00962689 |
2009H0067
KL2RR025754 |
|
August 2009 |
November 2013 |
November 2013 |
August 20, 2009 |
April 28, 2017 |
|
- The Ohio State University
Columbus, Ohio, United States
|
|
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