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Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Sponsor: Apreo Health, Inc.
Summary
The objective of this study is to assess the safety and efficacy of Apreo BREATHE system when used to support native airways and release trapped air in the treatment of adult COPD patients with emphysema suffering from dyspnea due to hyperinflation despite optimal medical treatment. The Apreo BREATHE Airway Scaffold is a permanent implant designed to tent open native airways. The study will include up to 250 participants at up to 25 study centers located in the United States and Europe. Study subjects will be followed for 3 years. The main questions it aims to answer are: Is it safe? Does it work?
Key Details
Gender
All
Age Range
40 Years - 84 Years
Study Type
INTERVENTIONAL
Enrollment
250
Start Date
2025-07-15
Completion Date
2029-12-31
Last Updated
2026-04-06
Healthy Volunteers
No
Interventions
Apreo BREATHE Airway Scaffold
The experimental treatment involves placement of up to 6 Apreo BREATHE Airway Scaffolds (up to 3 per lung), in a single procedure using bronchoscopy and fluoroscopy. Treatment group subjects will also receive optimal medical management (OMM).
Optimal Medical Management (OMM)
Subjects will receive optimal medical management tailored to patient needs and per standard of care and as outlined in the 2024 GOLD report. This may include smoking cessation, vaccination, long-acting bronchodilator therapy, corticosteroids (when appropriate), and participation in or maintenance of an exercise program or pulmonary rehabilitation program.
Locations (21)
University of Alabama at Birmingham
Birmingham, Alabama, United States
Banner Health
Gilbert, Arizona, United States
University of California at Davis
Sacramento, California, United States
Mayo Clinic
Jacksonville, Florida, United States
Orlando Health
Orlando, Florida, United States
University of Chicago
Chicago, Illinois, United States
OSF St Francis Medical Center
Peoria, Illinois, United States
University of Kansas Medical Center Research Institute
Kansas City, Kansas, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
The Ohio State University
Columbus, Ohio, United States
Clinical Research Associates of Central Pennsylvania
DuBois, Pennsylvania, United States
Temple University
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Houston Methodist/Primary Critical Care
Houston, Texas, United States
Inova Health Care Services
Falls Church, Virginia, United States
Karl Landsteiner Institute - Klink Floridsdorf
Vienna, Austria
University Medical Center Groningen
Groningen, Netherlands
St. Bartholomew's Hospital
London, United Kingdom
Royal Brompton Hospital
London, United Kingdom