Multi-center Randomized Study Comparing Subsegmental and Segmental InterVapor Treatment for Severe Emphysema

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two different approaches to bronchoscopic thermal vapor ablation BTVA treatment using the InterVapor System in patients with severe emphysema. The study compares treating at least two subsegments in different lung segments versus treating at least one whole lung segment. This multi-center randomized controlled trial aims to provide precise treatment options for patients with severe emphysema while continuing optimal medical therapy. Participants are randomly assigned to one of two groups the experimental group receives BTVA treatment targeting at least two subsegments of different lung segments in a single procedure, while the control group receives treatment targeting at least one whole segment per procedure. Each patient undergoes a sequential treatment with a minimum of 6 weeks and up to 6 months between procedures, with a maximum treatment volume defined per procedure and cumulatively across two treatments. Alongside BTVA, all participants continue receiving medical therapy following GOLD guidelines throughout the study. During the study, patients will have follow-up visits at 1, 3, 6, and 12 months after the second procedure. These visits include tests to assess lung function, high-resolution CT scans, a 6-minute walk test, and questionnaires measuring quality of life and respiratory symptoms. The main outcome being evaluated is lung function improvement measured by FEV1 six months after the second procedure. Secondary outcomes include lung volume changes, other lung function measures, exercise capacity, symptom assessments, responder rates, and recording of any adverse events during and up to one year after treatment.

A Multi-center RCT to Evaluate Subsegmental BTVA Treatment for Severe Emphysema