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RECRUITING
NCT06891755
NA

Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3

Sponsor: Apreo Health, Inc.

View on ClinicalTrials.gov

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

Conditions

Interventions

DEVICE

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).

OTHER

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