A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema
Trial Parameters
Brief Summary
A Study at Two Hospitals Testing the Safety and Effectiveness of the IAB 50 Flex, a New Implant for Adults with Severe COPD or Emphysema
Eligibility Criteria
Inclusion Criteria: 1. Signed Informed Consent 2. Diagnosis of COPD/emphysema 3. At least 22-years of age 4. 18 ≤ BMI ≤ 32 5. 6-minute walk Distance of between 100 - and 400 meters 6. Stable disease with less than 10-mg prednisone (or equivalent) daily 7. Non-smoking for 4-months prior to screening interview (this includes tobacco, vaping, marijuana, etc.). 8. FEV1 between 15% and 45% of predicted value at baseline exam 9. FEV1/FVC \<70% 10. Subject has ≥25% emphysema destruction score in each lung defined by areas of low attenuation less than -950 HU, as determined by CT core lab. 11. Subject has homogeneous or heterogeneous emphysema, and at least one lung has a 15% difference between upper and lower lobes in emphysema destruction score less than -950 HU, as determined by CT core lab. 12. RV \> 175% of predicted value. 13. mMRC score ≥ 2 Exclusion Criteria: 1. Currently participating in another clinical study that involves surgery, interventional or pharmaceutical treatment 2. α-1 An