Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung - Study 3
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?
Description
Prospective, randomized, two arm, parallel group, concurrently controlled, open-label, multi-center clinical trial following up to 250 participants to 3 years. Each site will participate in a Roll-In phase prior to participation in the randomized phase of the study. Each site will enroll up to 2 subjects in this phase. Up to 50 subjects may be enrolled into the Roll-In cohort. Up to 200 subjects with bilateral emphysema will be randomized at up to 25 centers in the United States centers and Europe. In the Randomized cohort, subjects will be randomized to either a Treatment or Control group…
Eligibility
- Age range
- 40–84 years
- Sex
- All
- Healthy volunteers
- No
* Inclusion Criteria 1. Subject is at least 40, but not older than 84, years of age. 2. Subject has body mass index (BMI) of between 18 and 32, inclusive. 3. Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline. 4. Subject has mMRC score ≥ 2. 5. Subject can walk ≥100 meters in 6 minutes. 6. Subject has ≥25% emphysema destruction score in each lung as quantified on baseline HRCT scan (low attenuation area less than -950HU) as determined by the CT core lab. 7. Subject has homogeneous or heterogeneous emphysema, and at least one lun…
Interventions
- DeviceApreo 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).
- OtherOptimal 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 (22)
- University of Alabama at BirminghamBirmingham, Alabama
- Banner HealthGilbert, Arizona
- University of California at DavisSacramento, California
- Mayo ClinicJacksonville, Florida
- Orlando HealthOrlando, Florida
- University of ChicagoChicago, Illinois