At a glance
ClinicalIndex Comparison RecordN/ACompleted· 203 enrolled
Drug / intervention
Relieva Balloon Sinuplasty Systemdevice
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.
Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
In Brief
An observational study evaluating Relieva Balloon Sinuplasty System for Sinusitis. Completed, enrolled 203 participants across 3 sites.
Detailed Summary
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
Study Details
Timeline
N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2010
First PostedApr 2010
Primary CompletionJan 2012
Study CompletionJul 2012
TodayJul 2026
First PostedApr 21, 2010
Enrollment StartApr 1, 2010
Primary CompletionJan 1, 2012
Study CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 16.2 years ago
Interventions
Relieva Balloon Sinuplasty Systemdevice
Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis