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

Integra LifeSciences

Status: Completed

Conditions: Recurrent Acute Rhinosinusitis

Treatments: Other: medical therapy; Device: balloon sinus dilation

Study type: Interventional

Funder types: Industry

Identifiers

NCT01714687

CPR005030

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

59 participants in 2 patient groups

balloon sinus dilation

Active Comparator group

Description:

Balloon sinus dilation will be conducted in-office under local anesthesia.

Treatment:

Device: balloon sinus dilation

Other: medical therapy

medical therapy

Active Comparator group

Description:

Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.

Treatment:

Other: medical therapy