Study of Bronchoscopic Lung Volume Reduction Using Thermoablation for Severe Emphysema in Adults Aged 40 to 75

What this Trial Is About

Researchers are evaluating bronchoscopic lung volume reduction using thermoablation as a treatment for patients with severe emphysema. This prospective, two-arm, randomized, open-label trial compares this intervention combined with standard conservative therapy against standard therapy alone, following Global Initiative for Chronic Obstructive Lung Disease GOLD guidelines. The study aims to contribute evidence on the benefits and safety of this procedure to provide appropriate care for emphysema patients. The trial involves two groups one receiving bronchoscopic lung volume reduction with thermal ablation using the InterVaporAE System in addition to standard care, and the other receiving only standard conservative therapy. The InterVaporAE System delivers heated water vapor to targeted lung areas, causing tissue remodeling and volume reduction. Participants in the intervention group may receive up to two partial treatments. Participants will be monitored over several months with assessments including patient-reported quality of life, lung function tests like FEV1 and residual volume, vital status checks, 6-minute walk tests, and monitoring for serious adverse events and exacerbations. Follow-up evaluations occur at 3, 9, and 12 months, with the primary outcome measured at 9 months. The study duration and procedures are designed to evaluate the impact and safety of the bronchoscopic treatment compared to standard care.

BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation