Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

NCT01685229 | Completed Results

• 1 other identifier: CPR005028
• Study Type: observational
• Target: 198
• Locations: 1 country
• Sites: 20

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.

Conditions

Sinusitis

Outcome Measures

Primary Outcomes (1)

• Comparison of Change in Chronic Sinusitis Survey (CSS) Score at 24 Weeks Compared to Baseline

  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.

  24 weeks post treatment

Secondary Outcomes (10)

• Comparison of Change Measured by CSS Medication and Sinusitis Symptom Subscores and Total Score From Baseline

  12, 24, and 52 weeks post treatment

• Change in RSDI

  12, 24 and 52 weeks post treatment

• Change in SNOT-20

  12 weeks, 24 weeks, 52 weeks post treatment

• Change in Disease-specific Medication Usage

  12, 24 and 52 weeks post treatment

• Missed Days Work/School

  12, 24 and 52 weeks post treatment

Study Arms (2)

Balloon Sinus Dilation

Subjects with chronic sinusitis electing to have a balloon sinus dilation

Device: Balloon sinus dilation

Medical Management

Subjects with chronic sinusitis electing to continue with medical therapy

Drug: Medical Management

Interventions

Balloon sinus dilation DEVICE

Subjects electing continued medical therapy group will not have balloon sinus dilation intervention. Subjects electing balloon sinus dilation group will have balloon sinus dilation intervention.

Also known as: Acclarent Balloon Sinuplasty System

Balloon Sinus Dilation

Medical Management DRUG

Subjects who select to continue on medical management rather than have a BSD procedure.

Medical Management

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult subjects age 19 or older with radiographically documented CRS

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (20)

Unknown Facility

Denver, Colorado, United States

Location

Unknown Facility

Miami, Florida, United States

Location

Unknown Facility

Tampa, Florida, United States

Location

Unknown Facility

Atlanta, Georgia, United States

Location

Unknown Facility

Savannah, Georgia, United States

Location

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Vidalia, Georgia, United States

Location

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Chicago, Illinois, United States

Location

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Rockford, Illinois, United States

Location

Unknown Facility

South Bend, Indiana, United States

Location

Unknown Facility

Louisville, Kentucky, United States

Location

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Neptune City, New Jersey, United States

Location

Unknown Facility

Dublin, Ohio, United States

Location

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Frisco, Texas, United States

Location

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McKinney, Texas, United States

Location

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Plano, Texas, United States

Location

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Charlottesville, Virginia, United States

Location

Unknown Facility

Norfolk, Virginia, United States

Location

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Richmond, Virginia, United States

Location

Unknown Facility

Beaver Dam, Wisconsin, United States

Location

Unknown Facility

Wauwatosa, Wisconsin, United States

Location

MeSH Terms

Conditions

Sinusitis

Interventions

Practice Management, Medical

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Paranasal Sinus Diseases; Nose Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Practice Management; Professional Practice; Organization and Administration; Health Services Administration

Results Point of Contact

• Title: Clinical Manager
• Organization: Acclarent Inc.

PChen126@ITS.JNJ.com

949-453-6408

Study Officials

• Spencer Payne, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

• Christopher Melroy, MD

  Georgia Nasal and Sinus Institute

  PRINCIPAL INVESTIGATOR

• Boris Karanfilov, MD

  Ohio Sinus Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 14, 2012
• Study Start: September 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: August 1, 2015
• Last Updated: July 12, 2024
• Results First Posted: May 13, 2019

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share

Locations

US (20)