Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
Sponsor: Apreo Health, Inc. • ClinicalTrials.gov ID: NCT06891755
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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?
Interventions
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Apreo BREATHE Airway Scaffold
(Device)
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).
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Optimal Medical Management (OMM)
(Other)
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.
Eligibility criteria
Conditions
Locations
- 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 — Jascksonville, 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
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States
- Karl Landsteiner Institute - Klink Floridsdorf — Vienna, Austria
- Thoraxklinik Heidelberg — Heidelberg, Germany
- University Medical Center Groningen — Groningen, Netherlands
- St. Bartholomew's Hospital — London, United Kingdom
- Royal Brompton Hospital — London, United Kingdom
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Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
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