Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS2)
A prospective, single-arm, multi-center, post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat chronic rhinosinusitis (CRS). All products intended for use in this study have been FDA cleared for sale in the U.S.A.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)|
- Change of Lund-MacKay CT scan scores and SNOT-20 scores at baseline and 24-weeks [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
- Tolerability and Pain scores on a visual analog scale [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: No ]Procedure Tolerability: Tolerability will be based on subject-reported pain during and immediately following the procedure. Pain and subject tolerability of the procedure will be reported using Visual Analog Scale (VAS) and the global assessment questionnaire.
|Study Start Date:||April 2010|
|Estimated Study Completion Date:||September 2012|
|Primary Completion Date:||April 2011 (Final data collection date for primary outcome measure)|
Treatment of sinusitis using balloon tools
Device: Relieva Balloon Sinuplasty System
Sinuplasty balloon tools for treatment of chronic rhinosinusitis