Multicenter Study Evaluating Safety and Effectiveness of the Implantable Artificial Bronchus Device in Adults With Severe Emphysema or COPD

What this Trial Is About

Researchers are evaluating a new therapy called the Implantable Artificial Bronchus IAB for adults with severe COPD or emphysema. This open-label, multicenter trial involves up to twelve sites in the United States and three sites in the Netherlands, Germany, and Brazil. The study aims to assess how well the IAB works and its safety in adults suffering from this lung condition. There is no control group in this study, focusing solely on those receiving the treatment. Participants will receive up to 10 polymer-based airway stents called Implantable Artificial Bronchi, which are placed permanently into diseased lung lobes through a bronchoscopic procedure using a special delivery system. The treatment is given in one study group where all subjects receive the IAB device. The therapy is designed to support lung function by targeting damaged areas in the lungs affected by emphysema. During the study, participants will be monitored through various assessments including pulmonary function tests, exercise tolerance, and questionnaires measuring breathlessness. Researchers will track changes in lung volume and other lung function measures 90 days after the last implant. Safety will be evaluated by recording any adverse effects related to the device. The total study duration and detailed follow-up procedures are designed to thoroughly understand the treatments impact on lung health.

A Multi Center Study Testing a New Implant for Adults With Severe Emphysema