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

Integra LifeSciences Corporation59 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Recurrent Acute Rhinosinusitis

Interventions

balloon sinus dilationDEVICE

medical therapyOTHER

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (5)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Atlanta, Georgia, United States

Unnamed facility

Las Vegas, Nevada, United States

Unnamed facility

Dallas, Texas, United States

Unnamed facility

Outcomes

Primary Outcomes

CSS Total Score Change From Baseline to 24 Week Visit

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey to evaluate surgical outcomes for CRS patients. The CSS asks three questions about symptoms and three questions about medication usage and yields a symptom subscore, a medication subscore, and a total score. Scale values include "0 Weeks" (minimum), "1-2 Weeks", "3-4 Weeks", "5-6 Weeks", and "7-8 Weeks" (maximum). The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). Subscores are averaged to calculate a total score. Higher score indicates better outcomes. The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects randomized to BSD versus medical management only. Change is assessed by using the Mean Change for the CSS total score at 24 weeks compared to baseline. (24-week CSS total score minus Baseline CSS total score). Higher score indicates greater improvement.

Time frame: 24 Week Visit

Secondary Outcomes

CSS Sub-score Changes From Baseline Over 48 Weeks, and CSS Total Score Over 48 Weeks

The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("0 Weeks" (minimum) to "7-8 Weeks" (maximum)) used to evaluate surgical outcomes for CRS patients. The CSS asks 3 questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score. The symptom-based section contains pain or pressure, nasal congestion or difficulty to breathe through the nose, and rhinorrhea or postnasal drip. The medication-based section contains: antibiotics, prescription nasal sprays, and sinus medications in pill form. The severity of symptoms is scored 0 (none) to 4 (severe), and a total score is calculated from 0 (worst) to 100 (best). The Secondary Endpoint is the comparison of change as measured by average CSS medication and sinusitis symptom sub-scores over 24 and 48 weeks, and average total CSS score over 48 weeks for subjects randomized to BSD versus medical management. Higher score indicates greater improvement.

Time frame: 8, 16, 24, 32, 40, and 48 Weeks

RSDI Total and Sub-score Changes From Baseline Over 48 Weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.