A Multicenter, Prospective Trial Evaluating the Safety and Efficacy of the Implantable Artificial Bronchus (IAB) in Adults Suffering From Severe Emphysema
Pulmair Medical, Inc.
Summary
A study taking place at multiple sites in the United States, Europe and Brazil to evaluate how well a new therapy for severe COPD/emphysema works, and how safe it is.
Description
IAB-2 is an open-label (unblinded), multicenter, prospective trial of the Implantable Artificial Bronchus (IAB) in adults suffering from severe COPD/emphysema. There is no control group or comparator. The study will be conducted at as many as twelve sites in the United States and three sites outside of the US, in the Netherlands, Germany and Brazil.
Eligibility
- Age range
- 22+ years
- Sex
- All
- Healthy volunteers
- No
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 between 100-meters and 400-meters at baseline exam. 6. Stable disease with less than 10-mg prednisone (or equivalent) daily 7. Non-smoking for 4-months prior to screening interview (including tobacco, vaping, marijuana, etc.). 8. FEV1 between 15% and 50% 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 \<-950 HU, as determined by CT core l…
Interventions
- DeviceImplantable Artificial Bronchus
The Implantable Artificial Bronchus (IAB) is a tapered, flexible and fenestrated polymer-based airway stent that is implanted bronchoscopically using a proprietary delivery system into diseased lungs of patients with emphysema.
Locations (4)
- University of California, San FranciscoSan Francisco, California
- University of California, San FranciscoSan Francisco, California
- Northwestern UniversityChicago, Illinois
- Beth Israel Deaconess Medical CenterBoston, Massachusetts