NCT02291549

S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: Intersect ENT · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Chronic Sinusitis
• Nasal Polyposis

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
DRUG	Mometasone furoate nasal spray	Mometasone furoate nasal spray (200mcg) once daily
PROCEDURE	Sham	In-office bilateral sham procedure, consisting of advancement of a delivery system with the S8 Sinus Implant into the ethmoid sinuses followed by removal without deployment.

Timeline

• Start date: 2014-12-01
• Primary completion: 2016-10-01
• Completion: 2016-10-01
• First posted: 2014-11-14
• Last updated: 2018-08-15
• Results posted: 2018-07-09

Locations

40 sites across 1 country: United States

Regulatory

• FDA-regulated drug study