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Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps — RESOLVE  

Nasal Polyps Clinical Trial

Official title:
A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction

Clinical Trial Summary

The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.

Clinical Trial Description

RESOLVE is a randomized (1:1), sham-controlled, parallel group, double-blind multicenter study in 100 chronic sinusitis patients who had prior endoscopic sinus surgery and presented with recurrent nasal polyps. The objective of the study was to assess the safety and efficacy of the S8 Sinus Implant, a steroid-eluting sinus implant, consisting of a bioabsorbable self-expanding sinus implant coated with 1350 mcg of mometasone furoate (MF) and a single-use delivery system. Implant is placed in-office in the ethmoid sinus under local anesthesia. The coating on the S8 implant provides controlled release of MF to the sinus mucosa over 90 days, with the majority of drug released within 60 days. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01732536
Study type Interventional
Source Intersect ENT
Contact
Status Completed
Phase Phase 2/Phase 3
Start date January 2013
Completion date May 2014
View Details
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