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S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps — RESOLVE_II  

Chronic Sinusitis Clinical Trial

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

Clinical Trial Summary

The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.

Clinical Trial Description

The RESOLVE II Study is a randomized, sham-controlled, double-blind, parallel arm multicenter trial conducted in up to 45 clinical centers (academic and private) across the United States in 300 adults with chronic sinusitis, who are indicated for revision surgery because of recurring nasal obstruction/congestion symptoms and bilateral ethmoid polyposis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02291549
Study type Interventional
Source Intersect ENT
Contact
Status Completed
Phase Phase 3
Start date December 2014
Completion date October 2016
View Details
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