Overview

This trial is active, not recruiting.

Condition recurrent acute rhinosinusitis
Treatments balloon sinus dilation, medical therapy
Sponsor Acclarent
Start date October 2012
End date October 2015
Trial size 59 participants
Trial identifier NCT01714687, CPR005030

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (subject)
Primary purpose treatment
Arm
(Active Comparator)
Balloon sinus dilation will be conducted in-office under local anesthesia.
balloon sinus dilation balloon sinuplasty
medical therapy medical management
(Active Comparator)
Medical therapy as needed per subject's specific disease and as determined by the investigators' clinical judgment.
medical therapy medical management

Primary Outcomes

Measure
Change in disease-specific patient-reported quality of life (QOL)
time frame: 24 weeks post treatment

Secondary Outcomes

Measure
Change in disease-specific patient-reported quality of life
time frame: 24 and 48 weeks post treatment
Change in disease-specific and general health-related quality of life
time frame: 8, 24 and 48 weeks post treatment
Change in disease-specific medication usage
time frame: 24 and 48 weeks post treatment
Missed days work/school and medical care visits due to sinusitis
time frame: 24 and 48 weeks post treatment
Number of sinus infections
time frame: 48 weeks post treatment
Number of subjects electing procedure (cross-over)
time frame: 48 weeks post treatment
Post-procedure return to normal activity (RTNA)
time frame: 2 weeks post treatment

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Comparison of Balloon Sinuplasty In-Office Versus Medical Management for Recurrent Acute Sinusitis Patients: A Randomized Controlled Study (CABERNET)
Principal investigator Ashley Sikand, MD
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Acclarent.