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?
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?
Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
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University of Alabama at Birmingham, Birmingham, Alabama, United States, 35233
Banner Health, Gilbert, Arizona, United States, 85234
Mayo Clinic, Jacksonville, Florida, United States, 32224
Orlando Health, Orlando, Florida, United States, 32806
University of Kansas Medical Center Research Institute, Kansas City, Kansas, United States, 66160
University of Michigan, Ann Arbor, Michigan, United States, 48109
The Ohio State University, Columbus, Ohio, United States, 43210
Clinical Research Associates of Central Pennsylvania, DuBois, Pennsylvania, United States, 15801
Temple University, Philadelphia, Pennsylvania, United States, 19140
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
40 Years to 84 Years
ALL
No
Apreo Health, Inc.,
Gerard Criner, MD, PRINCIPAL_INVESTIGATOR, Temple University
2029-12-31