Clinical Trial

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

Study acronym: BREATHE-3
Recruiting
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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?
Protocol Amendment History 8 amendments
This ClinicalTrials.gov record has been amended 8 times since 2025-03-18; most recent amendment 2026-04-22.
Status change: Not Yet Recruiting → Recruiting 2025-07-29
Trial Details
NCT Number NCT06891755
Lead Sponsor Apreo Health, Inc.
Conditions COPD, Emphysema
Enrollment 250 participants
Start Date 2025-07-15
Primary Completion 2027-09-30 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-24