| 1 |
NCT02506426 |
Recruiting |
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, Senior) |
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, Senior) |
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, Senior) |
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) |
NCT02931604 |
SNS001 |
|
January 2017 |
November 2019 |
January 2020 |
October 13, 2016 |
October 13, 2016 |
|
|
| 5 |
NCT02291549 |
Completed |
Clinical Evaluation of Safety and Efficacy of S8 Sinus Implant in Chronic Sinusitis Patients |
- Chronic Sinusitis
- Nasal Polyposis
|
- Drug: S8 Sinus Implant
- Drug: Nasonex steroid nasal spray
|
Interventional |
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
- Change in Nasal Obstruction/Congestion Score from baseline to Day 30
- Change in bilateral polyp grade from baseline to Day 90
|
300 |
All |
18 Years and older (Adult, Senior) |
NCT02291549 |
P500-1113 |
RESOLVEII |
December 2014 |
October 2016 |
October 2016 |
November 14, 2014 |
August 18, 2017 |
|
- 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, Senior) |
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: Single (Participant)
- 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, Senior) |
NCT02266810 |
P500-0514 |
PROGRESS |
September 2014 |
April 2016 |
October 2016 |
October 17, 2014 |
October 6, 2017 |
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 |
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, Senior) |
NCT00236652 |
CR004678 |
|
November 2003 |
|
June 2005 |
October 12, 2005 |
June 10, 2011 |
|
|
| 9 |
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, Senior) |
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
|
| 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, Senior) |
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 |
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, Senior) |
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
|
| 12 |
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, Senior) |
NCT01066416 |
0001 |
|
July 2009 |
December 2015 |
December 2015 |
February 10, 2010 |
February 10, 2010 |
|
- Evanston Hospital
Evanston, Illinois, United States
|
| 13 |
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, Senior) |
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
|
| 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, Senior) |
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, Senior) |
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 |
NCT01732536 |
Completed |
Safety and Efficacy of a Steroid-Releasing Sinus Implant for Recurrent Sinus Obstruction |
|
- Drug: S8 Sinus Implant
- Procedure: Sham procedure
|
Interventional |
Phase 2
Phase 3 |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Triple (Participant, Care Provider, Outcomes Assessor)
- Primary Purpose: Treatment
|
- nasal obstruction/congestion
- nasal polyposis
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT01732536 |
P500-1012 |
RESOLVE |
January 2013 |
November 2013 |
May 2014 |
November 26, 2012 |
March 21, 2017 |
|
- California Sinus Centers
Atherton, California, United States - Cedars-Sinai Medical Center
Los Angeles, California, United States - Sacramento Ear, Nose and Throat
Sacramento, California, United States - (and 16 more...)
|
| 17 |
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, Senior) |
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...)
|
| 18 |
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, Senior) |
NCT01525862 |
2091-001 |
|
December 2011 |
January 2013 |
January 2013 |
February 3, 2012 |
February 13, 2013 |
|
- Entellus Medical
Maple Grove, Minnesota, United States
|
| 19 |
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, Senior) |
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
|
| 20 |
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, Senior) |
NCT00236522 |
CR002809 |
|
October 2002 |
|
April 2004 |
October 12, 2005 |
June 10, 2011 |
|
|
| 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, Senior) |
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 |
NCT02509663 |
Unknown † |
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)
|
- 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, Senior) |
NCT02509663 |
6190 |
SIBA |
December 2015 |
September 2017 |
|
July 28, 2015 |
November 26, 2015 |
|
- ORL and facial surgery department, Hautepierre Hospital, Strasbourg's University Hospitals
Strasbourg, France
|
| 23 |
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, Senior) |
NCT03066908 |
SLSUS05 |
CRS |
June 20, 2018 |
December 2018 |
December 2018 |
March 1, 2017 |
April 18, 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...)
|
| 24 |
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, Senior) |
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...)
|
| 25 |
NCT01894503 |
Completed |
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
|
- Successful deployment on implant into the ethmoid sinus
|
5 |
All |
18 Years and older (Adult, Senior) |
NCT01894503 |
P500-0513 |
S8PK |
June 2013 |
October 2013 |
October 2013 |
July 10, 2013 |
March 14, 2017 |
|
- Sacramento ENT
Sacramento, California, United States
|
| 26 |
NCT03336671 |
Recruiting |
Management of Pediatric Chronic Rhinosinusitis in Asthmatic Children |
- Chronic Sinusitis
- Adenoid Disease - Chronic
|
- Procedure: Adenoidectomy plus 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 |
November 9, 2017 |
|
- SUNY Upstate Medical University
Syracuse, New York, United States
|
| 27 |
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, Senior) |
NCT00249210 |
CR005485 |
|
August 1993 |
|
July 1994 |
November 7, 2005 |
June 10, 2011 |
|
|
| 28 |
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, Senior) |
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
|
| 29 |
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, Senior) |
NCT00705237 |
LCID 2007-118 |
|
March 2008 |
May 2008 |
February 2009 |
June 25, 2008 |
February 18, 2009 |
|
- Lahey Clinic
Burlington, Massachusetts, United States
|
| 30 |
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, Senior) |
NCT02975310 |
CTO-0801 |
|
April 11, 2017 |
November 2018 |
April 2019 |
November 29, 2016 |
September 25, 2017 |
|
- Ottawa Hospital Research Institute
Ottawa, Ontario, Canada
|
| 31 |
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) |
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...)
|
| 32 |
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, Senior) |
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
|
| 33 |
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
|
| 34 |
NCT02077322 |
Recruiting |
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.
|
96 |
All |
19 Years and older (Adult, Senior) |
NCT02077322 |
Synechiae-2014 |
SYNECHIAE |
March 2014 |
May 2017 |
May 2017 |
March 4, 2014 |
October 13, 2016 |
|
- St. Paul's Hospital Sinus Centre
Vancouver, British Columbia, Canada
|
| 35 |
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, Senior) |
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
|
| 36 |
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, Senior) |
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
|
| 37 |
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, Senior) |
NCT00335309 |
ENT-1/2005
20051031 |
|
October 2005 |
August 2013 |
August 2013 |
June 9, 2006 |
October 8, 2013 |
|
|
| 38 |
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, Senior) |
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
|
| 39 |
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, Senior) |
NCT00534768 |
KUH5551813 |
|
January 2003 |
|
|
September 26, 2007 |
January 14, 2008 |
|
- Kuopio University Hospital
Kuopio, Finland
|
| 40 |
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, Senior) |
NCT00231062 |
CP-00313 |
|
April 2005 |
June 2006 |
June 2006 |
October 4, 2005 |
July 8, 2011 |
July 8, 2011 |
|
| 41 |
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, Senior) |
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...)
|
| 42 |
NCT02880514 |
Active, not recruiting |
A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation |
|
- Device: Propel Mini Sinus Implant
- Procedure: In-office Sinus Dilation
|
Interventional |
Not Applicable |
|
Industry |
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Single (Participant)
- Primary Purpose: Treatment
|
|
100 |
All |
18 Years and older (Adult, Senior) |
NCT02880514 |
P500-0616 |
FRONTIER |
August 2016 |
September 2017 |
September 2017 |
August 26, 2016 |
March 21, 2017 |
|
- 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...)
|
| 43 |
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) |
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
|
| 44 |
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, Senior) |
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
|
| 45 |
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, Senior) |
NCT02812199 |
461001P |
|
August 2016 |
December 2017 |
December 2017 |
June 24, 2016 |
May 2, 2017 |
|
- Herzliya Medical Center
Herzliya, Israel
|
| 46 |
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, Senior) |
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
|
| 47 |
NCT01919411 |
Active, not recruiting |
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
|
140 |
All |
18 Years and older (Adult, Senior) |
NCT01919411 |
11-053H |
|
February 2013 |
March 31, 2018 |
March 31, 2018 |
August 9, 2013 |
January 19, 2018 |
|
- Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, United States
|
| 48 |
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, Senior) |
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
|
| 49 |
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, Senior) |
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
|
| 50 |
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, Senior) |
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
|
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