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

Intersect ENT105 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

105

Conditions

Chronic Sinusitis

Interventions

Sinus Stent with drug coatingDEVICE

Sinus stent coated with 370 ug of the corticosteroid mometasone furoate

Non Coated Sinus StentDEVICE

Sinus stent (visually identical) without drug coating

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Central California ENT

Fresno, California, United States

Colorado ENT & Allergy

Colorado Springs, Colorado, United States

Northwestern University

Chicago, Illinois, United States

Outcomes

Primary Outcomes

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.

Time frame: 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

Time frame: 90 days

Secondary Outcomes

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.

Time frame: 30 days

Data from ClinicalTrials.gov

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