- Bronchoscopic RElease of Air Trapped in Hyperinflated Emphysematous Lung – Study 3 — Recruiting • Non-phase study • Respiratory / COPD / Asthma • NCT06891755.
- 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….
- Sponsor: Apreo Health, Inc.
Verify eligibility, endpoints and current status on the original source registry before acting on this summary.
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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…
- Subject is at least 40, but not older than 84, years of age.
- Subject has body mass index (BMI) of between 18 and 32, inclusive.
- Subject has completed a documented pulmonary rehabilitation program within 12 months prior to Baseline.
- Subject has mMRC score ≥ 2.
- Subject can walk ≥100 meters in 6 minutes.
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.