250
Participants
Start Date
July 15, 2025
Primary Completion Date
September 30, 2027
Study Completion Date
December 31, 2029
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.
RECRUITING
Clinical Research Associates of Central Pennsylvania, DuBois
RECRUITING
Temple University, Philadelphia
RECRUITING
Mayo Clinic, Jacksonville
RECRUITING
Orlando Health, Orlando
RECRUITING
University of Alabama at Birmingham, Birmingham
RECRUITING
The Ohio State University, Columbus
RECRUITING
Cleveland Clinic Foundation, Cleveland
RECRUITING
University of Michigan, Ann Arbor
RECRUITING
University of Chicago, Chicago
RECRUITING
University of Kansas Medical Center Research Institute, Kansas City
RECRUITING
Banner Health, Gilbert
RECRUITING
Beth Israel Deaconess Medical Center, Boston
RECRUITING
University Medical Center Groningen, Groningen
Lead Sponsor
Apreo Health, Inc.
INDUSTRY