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

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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.


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
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