At a glance
ClinicalIndex Comparison RecordN/ACompleted· 50 enrolled
Drug / intervention
Steroid-Eluting Sinexus Intranasal Splintdevice
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 the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
In Brief
A clinical study evaluating Steroid-Eluting Sinexus Intranasal Splint for Chronic Sinusitis. Completed, enrolled 50 participants across 1 site.
Detailed Summary
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus Intranasal Splint 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
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
Primary CompletionJun 2009
First PostedJun 2009
Study CompletionDec 2009
TodayJul 2026
First PostedJun 3, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.1 years ago
Interventions
Steroid-Eluting Sinexus Intranasal Splintdevice
Intranasal drug-coated splint placed after functional endoscopic surgery (FESS)