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RejuvenAir® System Trial for COPD With Chronic Bronchitis
Sponsor: CSA Medical, Inc.
Summary
Chronic Obstructive Pulmonary Disease (COPD) is defined as an impaired ability to move air within the lungs and is a major public health problem that is projected to rank fifth worldwide in terms of disease burden and third in terms of mortality. Chronic bronchitis (CB) is a common clinical phenotype within the umbrella of a COPD diagnosis and is classically defined as chronic cough and sputum production for 3 months a year for 2 consecutive years2, but many studies have used different definitions to define it- chronic cough and sputum production for one year or cough and sputum production on most days of the week. CB is associated with multiple clinical consequences, including; the worsening of lung function decline, increasing risk of acute exacerbations of COPD, increased risk of developing pneumonia, reduced health related quality of life, and an increase in all-cause mortality.
Official title: A Sham Controlled Prospective Randomized Clinical Trial of the RejuvenAir® System for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease With Chronic Bronchitis
Key Details
Gender
All
Age Range
40 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
210
Start Date
2020-07-09
Completion Date
2026-09
Last Updated
2024-06-03
Healthy Volunteers
No
Conditions
Interventions
RejuvenAir System
RejuvenAir Metered CryoSpray
Sham Control Procedure
Sham Control Procedure
Locations (27)
Honor Health
Scottsdale, Arizona, United States
El Camino Hospital
Mountain View, California, United States
University of California, Davis Medical Center
Sacramento, California, United States
Advanced Pulmonary Research Institute
Loxahatchee Groves, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Northwestern University
Chicago, Illinois, United States
Louisiana State University Medical Center
Shreveport, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Johns Hopkins Universtiy
Baltimore, Maryland, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Spectrum Health
Grand Rapids, Michigan, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States
Cooper Health System
Camden, New Jersey, United States
Duke University
Durham, North Carolina, United States
University Of Cincinnati
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State Universisty
Columbus, Ohio, United States
Clinical Research Associates of Central PA
Altoona, Pennsylvania, United States
Temple University - Of the Commonwealth System of Higher Education
Philadelphia, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Prisma Health - Midlands
Columbia, South Carolina, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
St. David's Georgetown Hospital
Georgetown, Texas, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
The Royal Brompton Hospital
London, United Kingdom