Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients (CABERNET)

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