NCT01732536

Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps

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

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Chronic Sinusitis
• Nasal Polyps

Interventions

Type	Name	Description
DRUG	S8 Sinus Implant	In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
PROCEDURE	Sham procedure	In-office bilateral sham procedure
DRUG	Mometasone furoate nasal spray	Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Timeline

• Start date: 2013-01-01
• Primary completion: 2013-11-01
• Completion: 2014-05-01
• First posted: 2012-11-26
• Last updated: 2018-07-20
• Results posted: 2018-07-20

Locations

19 sites across 1 country: United States

Regulatory

• FDA-regulated drug study