Conditions: Chronic Sinusitis Nasal Polyposis
Keywords: endoscopic sinus surgery corticosteroid chronic rhinosinusitis mometasone furoate polyposis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 300
Healthy volunteers: no

Brief 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.

Arms:
arm 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses

Mometasone furoate nasal spray (200mcg) once daily arm 2: In-office bilateral sham procedure

Mometasone furoate nasal spray (200mcg) once daily

Interventions: intervention 1: S8 Sinus Implant intervention 2: Mometasone furoate nasal spray intervention 3: Sham
Intervention descriptions: intervention 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses intervention 2: Mometasone furoate nasal spray (200mcg) once daily intervention 3: 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.

Protocol document: