Conditions: Chronic Sinusitis Nasal Polyps
Keywords: corticosteroid-eluting sinus implant chronic rhinosinusitis mometasone furoate polyposis
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 100
Healthy volunteers: no

Brief 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.

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: Sham procedure intervention 3: Mometasone furoate nasal spray
Intervention descriptions: intervention 1: In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses intervention 2: In-office bilateral sham procedure intervention 3: Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90

Protocol document: