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In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia (FRONTIER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02880514
Recruitment Status : Completed
First Posted : August 26, 2016
Results First Posted : December 10, 2018
Last Update Posted : December 10, 2018
Sponsor:
Information provided by (Responsible Party):
Intersect ENT

Brief Summary:
A randomized controlled trial

Condition or disease Intervention/treatment Phase
Chronic Sinusitis Device: PROPEL Mini Sinus Implant Procedure: Balloon Sinus Dilation Alone Not Applicable

Detailed Description:
This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
Study Start Date : August 2016
Actual Primary Completion Date : December 2016
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PROPEL Mini Sinus Implant
Placement of the Propel Mini Sinus Implant in one frontal sinus ostia (FSO) assigned to the treatment group following in-office balloon dilation
Device: PROPEL Mini Sinus Implant
Sinus implant with 370 mcg of mometasone furoate released over 30 days
Other Name: PROPEL Mini

Procedure: Balloon Sinus Dilation Alone
Active Comparator: Balloon Sinus Dilation Alone
In-office balloon dilation of the contralateral frontal sinus ostia (FSO) without implant placement
Procedure: Balloon Sinus Dilation Alone



Primary Outcome Measures :
  1. Patency Rate [ Time Frame: Day 30 ]
    Patency of the frontal recess/frontal sinus ostia (FSO) was evaluated on a 3-point grading scale from 0 to 2, with 0=Patent, 1=Restenosed/partially occluded, and 2=Occluded. The percentage of sinuses with patency grade 0 and 1 was used to calculate the patency rate.


Secondary Outcome Measures :
  1. Inflammation Score [ Time Frame: Day 30 ]
    Inflammation visual analog scale (VAS) from 0 (no visible inflammation) to 100 (severe inflammation, involving significant and extensive erythema and edema and/or hypertrophy and/or polypoid changes)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria

  • Patient has provided written informed consent using a form approved by the reviewing IRB.
  • Patient is 18 years of age or older.
  • Patient is willing and able to comply with protocol requirements.
  • Patient has CRS defined as sinonasal inflammation persisting for more than 12 weeks and complains of at least 2 of the 4 following symptoms: nasal blockage/obstruction/congestion, nasal blockage/obstruction/congestion, nasal discharge (anterior/posterior), facial pain/pressure, reduction/loss of smell
  • CRS diagnosis confirmed by CT scan within 3 months prior to enrollment
  • Bilateral frontal sinusitis confirmed by Lund-Mackay score of ≥1 on each side
  • Post-endoscopic sinus surgery, patient has bilateral obstruction of the frontal sinus ostia by scarring and/or polypoid edema.
  • Patient is a candidate for an in-office balloon dilation procedure.
  • In the opinion of the investigator, treatment with the Propel Mini Sinus Implant as an adjunct to balloon sinus dilation is technically feasible and clinically indicated in the frontal sinus ostia.

Exclusion Criteria:

  • Expanded amount of ethmoid sinonasal polyps extending beyond the middle meatus of grade 3 or 4 unless reduced prior to randomization in the study.
  • Oral-steroid dependent condition such as chronic obstructive pulmonary disease (COPD) or other conditions.
  • Known history of allergy or intolerance to corticosteroids or mometasone furoate.
  • Clinical evidence of acute bacterial sinusitis or invasive fungal sinusitis.
  • Active viral illness (e.g., flu, shingles).
  • Clinical evidence of disease or condition expected to compromise survival or ability to complete follow-up assessments through Day 180 post-procedure.
  • Currently participating in another clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880514


Locations
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United States, California
Sacramento ENT
Sacramento, California, United States, 95815
United States, Florida
ENT Assoicates of South Florida
Boca Raton, Florida, United States, 33487
United States, Georgia
ENT of Georgia
Atlanta, Georgia, United States, 30342
United States, Kentucky
Advanced ENT and Allergy
Louisville, Kentucky, United States, 40207
United States, Louisiana
Associated Surgical Specialists
Covington, Louisiana, United States, 70433
United States, Missouri
St. Luke's ENT Specialists
Kansas City, Missouri, United States, 64111
United States, New Mexico
BreatheAmerica of Albuquerque
Albuquerque, New Mexico, United States, 87109
United States, New York
Madison ENT
New York, New York, United States, 10016
United States, Ohio
Ohio Sinus Institute
Dublin, Ohio, United States, 43016
Sponsors and Collaborators
Intersect ENT
Investigators
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Principal Investigator: Stacey Silvers Madison ENT

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Responsible Party: Intersect ENT
ClinicalTrials.gov Identifier: NCT02880514    
Other Study ID Numbers: P500-0616
First Posted: August 26, 2016    Key Record Dates
Results First Posted: December 10, 2018
Last Update Posted: December 10, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Intersect ENT:
Frontal Sinus
Balloon Dilation
Additional relevant MeSH terms:
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Sinusitis
Paranasal Sinus Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents