Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)
|ClinicalTrials.gov Identifier: NCT01107379|
Recruitment Status : Completed
First Posted : April 21, 2010
Results First Posted : September 18, 2014
Last Update Posted : September 18, 2014
|Condition or disease||Intervention/treatment|
|Sinusitis||Device: Relieva Balloon Sinuplasty System|
|Study Type :||Observational|
|Actual Enrollment :||203 participants|
|Official Title:||Optimization and Refinement of Technique in In-Office Sinus Dilation 2 (ORIOS 2)|
|Study Start Date :||April 2010|
|Primary Completion Date :||January 2012|
|Study Completion Date :||July 2012|
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
- Mean Intra-patient Change in SNOT-20 Score [ Time Frame: Baseline and 24 weeks ]
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 ]
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) ]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) ]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) ]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 ]Quality Of Life (QoL) evaluated by analysis of time to return to usual activities of daily living
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|