At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 100 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.
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
In Brief
A Phase 3 clinical trial evaluating S8 Sinus Implant, Sham procedure, and 1 other intervention for Chronic Sinusitis and Nasal Polyps. Completed, enrolled 100 participants across 19 sites.
Detailed Summary
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis, Nasal Polyps
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedNov 2012
Enrollment StartJan 2013
Primary CompletionNov 2013
Study CompletionMay 2014
TodayJul 2026
First PostedNov 26, 2012
Enrollment StartJan 1, 2013
Primary CompletionNov 1, 2013
Study CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 13.6 years ago
Interventions
S8 Sinus Implantdrug
In-office bilateral placement of the S8 Sinus Implant (mometasone furoate, 1350 mcg) in the ethmoid sinuses
Sham procedureprocedure
In-office bilateral sham procedure
Mometasone furoate nasal spraydrug
Two sprays in each nostril once daily, totaling 200 mcg of mometasone furoate throughout Day 90