A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).

Detailed Description
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The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS). The Propel implant is designed to provide a mechanical spacing function within the sinus anatomy to separate mucosal tissues, provide stabilization of the middle turbinate, and thereby prevent tissue adhesions from forming. The implant is coated with a small amount of mometasone furoate (a corticosteroid) in order to help minimize post surgical inflammation within the supported tissues. The study utilizes an intra-patient control design to assess the safety and efficacy of the drug-coated implant compared to the non-drug coated implant that is identical in appearance.

Official Title
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A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis

Conditions
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Chronic Sinusitis

Intervention / Treatment
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* Device: Sinus Stent with drug coating
* Device: Non Coated Sinus Stent


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient has bilateral chronic sinusitis confirmed by CT scan and defined as inflammation of the mucosa of the nose and paranasal sinuses of at least 8 consecutive weeks' duration. Patient is indicated for and has consented to FESS. FESS successfully completed without significant complication that in the opinion of the physician would confound study results and the patient's anatomy remains amenable to Sinus Stent placement. CT Imaging Inclusion Criteria: CS diagnosis confirmed and documented by CT Scan within 6 months of the procedure. Patient has minimum total CT score (Lund-Mackay method) of 6. • Patient has bilateral ethmoid sinus disease confirmed by CT. Exclusion Criteria: insulin dependent diabetics oral steroid dependent condition glaucoma, ocular hypertension, posterior subcapsular cataracts middle turbinate resection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Drug Coated<br>Sinus stent coated with steroid | Device: Sinus Stent with drug coating<br>* Sinus stent coated with 370 ug of the corticosteroid mometasone furoate<br>|
| Placebo Comparator: Non coated<br>Sinus stent without drug coating | Device: Non Coated Sinus Stent<br>* Sinus stent (visually identical) without drug coating<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Sinuses Requiring Post-operative Intervention | Post-operative interventions include either need for surgical adhesion lysis or the need for oral steroids prescription, as determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons. | 30-days | 
| Percentage of Patients With Clinically Significant Increase in Intra-ocular Pressure | clinically significant IOP elevation is a change from baseline of >10 mm Hg on sinus side with drug-coated implant but not on side with control implant | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Sinuses That Developed Frank Polyposis | Frank polyposis means polyps grade 2 or 3, which was determined from video-endoscopies reviewed by a panel of independent blinded sinus surgeons. | 30 days |