Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

Completed

• Conditions: Sinusitis
• Interventions: Device: Balloon sinus dilation; Drug: Medical Management

• Registration Number: NCT01685229
• Lead Sponsor: Integra LifeSciences Corporation

Brief Summary

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-09-01
• Study First Submitted: 2012-09-12
• Study First Submitted QC: 2012-09-12
• Study First Posted: 2012-09-14
• Primary Completion: 2015-04-01
• Study Completion: 2015-08-01
• Results First Submitted: 2016-04-29
• Results First Submitted QC: 2019-02-12
• Results First Posted: 2019-05-13
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-10
• Last Update Posted: 2024-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

Inclusion Criteria

• Males and females aged 19 or greater
• Diagnosis of Chronic Rhinosinusitis (CRS)
• Failure of appropriate medical management
• Radiographic evidence of inflammation of the paranasal sinuses
• Surgical candidate
• Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures
• Able to read and understand English

Exclusion Criteria

• Not suitable for balloon dilation for all peripheral sinuses that require treatment
• Clinically significant illness that may interfere with the evaluation of the study
• Patients involved in other clinical studies 30 days prior to study
• Pregnant or lactating females
• Patients unable to adhere to follow-up schedule or protocol requirements

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Balloon Sinus Dilation	Balloon sinus dilation	Subjects with chronic sinusitis electing to have a balloon sinus dilation
Medical Management	Medical Management	Subjects with chronic sinusitis electing to continue with medical therapy

Primary Outcome Measures

Name	Time	Method
Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline	24 weeks post treatment	The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") to evaluate surgical outcomes for CRS patients. The CSS asks three questions each about symptoms and medication usage, yielding a symptom subscore, a medication subscore, and a total score.; The duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks") and a total score is normalized from 0 (worst) to 100 (best).; The Primary Endpoint is the comparison of change in total CSS score over 24 weeks for subjects electing BSD versus medical management.; 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.

Secondary Outcome Measures

Name	Time	Method
Change in Disease-specific Medication Usage	12, 24 and 52 weeks post treatment
Number of Sinus Infections	24 and 52 weeks
Post-operative Return to Normal Activity (RTNA)	2 weeks post treatment
Change in SNOT-20	12 weeks, 24 weeks, 52 weeks post treatment	The Sino-Nasal Outcome Test (SNOT-20) is a validated questionnaire consisting of 20 symptom-directed questions and quality of life and health utility assessments.; Scale values range from 0 (No Problem) to 5 (Problem as bad as it can be).; Lower score indicates greater improvement.
Missed Days Work/School	12, 24 and 52 weeks post treatment
Number of Sinus-related Medical Care Visits	12 weeks, 24 weeks, 52 weeks post treatment
Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline	12, 24, and 52 weeks post treatment	The Chronic Sinusitis Survey (CSS) is a 6 question, duration-based survey ("during the past 8 weeks") 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 duration of symptoms is scored 0 ("7-8 Weeks") to 4 ("0 Weeks"), and a total score is normalized 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 at 12, 24, and 52 weeks , and average total CSS score at 12 and 52 weeks for subjects electing BSD versus medical management. Higher score indicates greater improvement.
Change in RSDI	12, 24 and 52 weeks post treatment	The Rhinosinusitis Disability Index (RSDI) is a 30-question survey which includes 3 individual subscales to measure physical, functional, and emotional scores as well as a total score. There is no specified recall period. Scale values are scored 0 ("Never") to 4 ("Always") and total score ranges from 0 (best) to 120 (worst). Subscores are summed to calculate a total score. Higher score indicates increased impact of sinus disease.; The Secondary Endpoint is comparison of change in patient-reported QOL as measured by RSDI total, physical, functional, and emotional sub-scores at 12, 24, and 52 weeks compared to baseline for subjects electing BSD versus medical management. Lower score indicates greater improvement (decreased impact of sinus disease).
Number of Medical Management Subjects Electing to Cross-over to Balloon Sinus Dilation Procedure	52 weeks
Number of Subjects Requiring Revision for Subjects Electing BSD	52 weeks	A revision is defined as an endoscopic sinus surgery procedure on sinuses successfully dilated during index (BSD) procedure due to documented worsening of condition related to those sinuses after the index (BSD) procedure.