Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
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 Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)|
- Mean Intra-patient Change in SNOT-20 Score [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Change in patient-reported quality of life survey, Sino-Nasal Outcome Test -20 (SNOT-20), using paired baseline and 24 week data.
The 20 question Sino-Nasal Outcome Test (SNOT-20) will be used to evaluate sinus symptoms and sinus-symptom related quality of life (QOL) at baseline and 24 weeks post-procedure. The change in SNOT-20 score at 24 months will be compared to the baseline SNOT-20 score. Each of the 20 questions in the SNOT-20 survey is scored on a scale of 0 to 5, where '0' represents 'no problem' and '5' represents 'problem as bad as it can be'. The 20 questions are expressed as a mean of the scores. Therefore, the minimum mean score is zero and the maximum mean score is 5.
- Mean Intra-patient Change in Lund-Mackay CT Scan Score [ Time Frame: Baseline and 24 weeks ] [ Designated as safety issue: No ]
Change in Lund-Mackay CT score for paired baseline and 24 week data.
The Lund-MacKay (LMK) CT (computed tomography) score is a scoring system to evaluate radiographic opacification of the paranasal sinuses. The LMK score will be evaluated at 24 weeks post-procedure compared to baseline. The LMK scoring system rates each of both the left and right frontal, maxillary, sphenoid, ostiomeatal complex, anterior ethmoid and posterior ethmoid sinuses on a scale of 0 to 2, where '0' is 'no opacification' and '2' is 'complete opacification'. The scores for a given subject are totaled and expressed as the LMK score, where zero is the minimum score, and 24 is the maximum score. A higher score represents greater sinus disease burden.
- Procedure Tolerability [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: No ]Procedure Tolerability: Proportion of Subjects rating procedure as tolerable or highly tolerable.
- Proportion of Sinuses Successfully Treated in the Office Using Balloon Catheter Tools and Traditional Endoscopic Tools as Necessary [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: No ]Technical success of the procedure is defined as successful treatment of sinuses intended for treatment in the office, using balloon catheter tools and traditional endoscopic tools, as necessary
- Proportion of Sinuses Successfully Treated in the Absence of Serious, Procedural Adverse Events. [ Time Frame: Day 0 (Day of Procedure) ] [ Designated as safety issue: Yes ]Procedure success is defined as achievement of the goal of the treatment. The physician will determine procedure success by visual endoscopic exam and absence of serious, procedural adverse events.
- Mean Number of Days to Return to Normal Activities [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
|Study Start Date:||April 2010|
|Study Completion Date:||July 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Balloon catheter device
Dilation of sinuses using Relieva Balloon Sinuplasty System
Device: Relieva Balloon Sinuplasty System
Sinuplasty balloon tools for dilation of sinuses in patients with chronic rhinosinusitis
Please refer to this study by its ClinicalTrials.gov identifier: NCT01107379
|United States, Alabama|
|Birmingham, Alabama, United States|
|United States, Nevada|
|Las Vegas, Nevada, United States|
|United States, Ohio|
|Dublin, Ohio, United States|
|Principal Investigator:||Michael Sillers, MD||Alabama Alabama Nasal and Sinus Center|