NCT01253577

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Chronic Sinusitis

Interventions

Type	Name	Description
DEVICE	Sinus Stent with drug coating	Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
DEVICE	Non Coated Sinus Stent	Sinus stent (visually identical) without drug coating

Timeline

• Start date: 2009-12-01
• Primary completion: 2010-10-01
• Completion: 2010-10-01
• First posted: 2010-12-03
• Last updated: 2015-06-22
• Results posted: 2015-04-13

Locations

11 sites across 1 country: United States