At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 105 enrolled
Drug / intervention
Sinus Stent with drug coating +1 moredevice
Likely dose
Not stated in 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 a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
In Brief
A Phase 3 clinical trial evaluating Sinus Stent with drug coating and Non Coated Sinus Stent for Chronic Sinusitis. Completed, enrolled 105 participants across 11 sites.
Detailed Summary
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Sinusitis
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartDec 2009
Primary CompletionOct 2010
First PostedDec 2010
TodayJul 2026
First PostedDec 3, 2010
Enrollment StartDec 1, 2009
Primary CompletionOct 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 15.6 years ago
Interventions
Sinus Stent with drug coatingdevice
Sinus stent coated with 370 ug of the corticosteroid mometasone furoate
Non Coated Sinus Stentdevice
Sinus stent (visually identical) without drug coating