Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 59
- Locations
- 5
- Primary Endpoint
- CSS Total Score Change From Baseline to 24 Week Visit
Study Overview
Brief Summary
This post-market study aims to compare health outcomes for Recurrent Acute Rhinosinusitis (RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •19 years of age or greater
- •diagnosis of recurrent acute rhinosinusitis
- •suitable candidate for office-based procedure
- •willing and able to read and sign informed consent and remain compliant with protocol and study procedures
- •able to read and understand English
Exclusion Criteria
- •diagnosis of chronic rhinosinusitis
- •prior sinus surgery
- •physician determined need for ancillary procedures
- •known immune deficiency, ciliary dysfunction and/or autoimmune disease
- •clinically significant illness that may interfere with evaluation of the study
- •participation in clinical studies 6 months prior to study participation
- •pregnant or lactating females
Arms & Interventions
balloon sinus dilation
Balloon sinus dilation will be conducted in-office under local anesthesia.
Intervention: balloon sinus dilation (Device)
balloon sinus dilation
Balloon sinus dilation will be conducted in-office under local anesthesia.
Intervention: medical therapy (Other)
medical therapy
Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
Intervention: medical therapy (Other)
Outcomes
Primary Outcomes
CSS Total Score Change From Baseline to 24 Week Visit
Time Frame: 24 Week Visit
The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.
Secondary Outcomes
- Return to Normal Activity(2 week)
- Frequency of Second Procedure(Up to 24 weeks)
- RSDI Total and Sub-score Changes From Baseline Over 48 Weeks(8, 24, and 48 Weeks)
- Medication Usage at 24 and 48 Weeks(24 Weeks and 48 Weeks)
- Sinus Infections and Sinus Severity - Part 1(24 Weeks and 48 Weeks)
- CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks(8, 16, 24, 32, 40, and 48 Weeks)
- Unscheduled Medical Care Visits Due to Sinusitis(24 Weeks and 48 Weeks)
- Sinus Infections and Sinus Severity - Part 2(24 Weeks)