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

✅ This trial is currently recruiting volunteers

If you think you might be eligible, speak to your GP or specialist about this trial before applying.

Status

Recruiting

Phase

Participants

ALL

Age Range

40 Years – 84 Years

About This Trial

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?

Who Can Join?

* 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 lung has a 15% difference between upper and lower lobes in emphysema destruction score (-910HU) as determined by the CT core lab. 8. Subject has bilateral heterogenous emphysema and pre-procedure post-bronchodilator RV ≥ 180% predicted, or one lung with homogenous emphysema and pre-procedure postbronchodilator RV ≥ 200% predicted. 9.…

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⚠ Always speak to your doctor before applying to any clinical trial.