Study of the Implantable Artificial Bronchus 50 Flex Device for Adults with Severe COPD and Emphysema at Two Hospitals

What this Trial Is About

Researchers are evaluating the safety and effectiveness of the Implantable Artificial Bronchus 50 Flex IAB 50 Flex, a new implant for adults who have severe COPD or emphysema. This trial is conducted at two hospitals and aims to study the implants impact on patients with these serious lung conditions. The study is sponsored by Pulmair Medical, Inc. and does not involve masking or blinding. Participants will undergo one or two procedures to place up to 10 polymer-based IAB implants in one or both lungs. These implants are designed to support the lungs affected by COPD or emphysema. The trial involves only the treatment group receiving the implant, with no comparison to placebo or other treatments. During the study, participants will be monitored for safety, focusing on the incidence of serious adverse events within 90 days after the last implant procedure. Researchers will assess lung function and disease stability through various tests and clinical evaluations. The study starts in February 2026 and will continue through December 2027, with participants undergoing screening and follow-up visits to evaluate treatment effects and overall health.

A Trial of the Implantable Artificial Bronchus 50 Flex in Patients With Severe Emphysema