CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
S8 Sinus Implant +2 moredrug
Likely dose
S8 Sinus Implant 1350 mcgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02291549
NCT02291549Phase 3Completed
CompareCT.gov

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

Intersect ENT·interventional·Posted Nov 14, 2014·Updated Aug 15, 2018

In Brief

A Phase 3 clinical trial evaluating S8 Sinus Implant, Mometasone furoate nasal spray, and 1 other intervention for Chronic Sinusitis and Nasal Polyposis. Completed, enrolled 300 participants across 40 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis, Nasal Polyposis
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 14, 2014
Enrollment StartDec 1, 2014
Primary CompletionOct 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.6 years ago

Interventions

S8 Sinus Implantdrug

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

Mometasone furoate nasal spraydrug

Mometasone furoate nasal spray (200mcg) once daily

Shamprocedure

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.