Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)
| Status: | Completed |
|---|---|
| Conditions: | Sinusitis |
| Therapuetic Areas: | Otolaryngology |
| Healthy: | No |
| Age Range: | 19 - Any |
| Updated: | 3/13/2019 |
| Start Date: | October 1, 2012 |
| End Date: | April 1, 2016 |
Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
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.
(RARS) patients treated with balloon sinus dilation (BSD) versus medical management alone.
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
We found this trial at
5
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