Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
NCT ID: NCT01685229
Last Updated: 2024-07-12
Study Results
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View full resultsBasic Information
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COMPLETED
198 participants
OBSERVATIONAL
2012-09-01
2015-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Balloon Sinus Dilation
Subjects with chronic sinusitis electing to have a balloon sinus dilation
Balloon sinus dilation
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.
Medical Management
Subjects with chronic sinusitis electing to continue with medical therapy
Medical Management
Subjects who select to continue on medical management rather than have a BSD procedure.
Interventions
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Balloon sinus dilation
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.
Medical Management
Subjects who select to continue on medical management rather than have a BSD procedure.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
19 Years
ALL
No
Sponsors
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Acclarent
INDUSTRY
Integra LifeSciences Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Spencer Payne, MD
Role: PRINCIPAL_INVESTIGATOR
University of Virginia
Christopher Melroy, MD
Role: PRINCIPAL_INVESTIGATOR
Georgia Nasal and Sinus Institute
Boris Karanfilov, MD
Role: PRINCIPAL_INVESTIGATOR
Ohio Sinus Institute
Locations
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Denver, Colorado, United States
Miami, Florida, United States
Tampa, Florida, United States
Atlanta, Georgia, United States
Savannah, Georgia, United States
Vidalia, Georgia, United States
Chicago, Illinois, United States
Rockford, Illinois, United States
South Bend, Indiana, United States
Louisville, Kentucky, United States
Neptune City, New Jersey, United States
Dublin, Ohio, United States
Frisco, Texas, United States
McKinney, Texas, United States
Plano, Texas, United States
Charlottesville, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Beaver Dam, Wisconsin, United States
Wauwatosa, Wisconsin, United States
Countries
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Other Identifiers
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CPR005028
Identifier Type: -
Identifier Source: org_study_id
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