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

Recurrent Acute Rhinosinusitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Recurrent Acute Rhinosinusitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:balloon sinus dilation

Other:medical therapy

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

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

Study Status

Completed

Start Date: October 1, 2012

Completed Date: April 1, 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Change in disease-specific patient-reported quality of life (QOL)

Secondary Outcome: Change in disease-specific patient-reported quality of life

Study sponsors, principal investigator, and references

Principal Investigator: Ashley Sikand, MD

Lead Sponsor: Acclarent

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01714687

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