Registry Study of Bronchoscopic Thermal Vapor Ablation Treatment for Patients with Upper Lobe Emphysema Tracking Long-Term Quality of Life and Lung Function Outcomes

What this Trial Is About

Researchers are studying the effects of Bronchoscopic Thermal Vapor Ablation BTVA using Uptake Medical Technology Inc.s InterVapor System for patients with heterogeneous upper lobe emphysema. This observational registry aims to understand the long-term impact of BTVA treatment on quality of life and other health measures in real-world clinical settings. Patients treated with InterVapor will be monitored to gather data on safety and effectiveness without a specific hypothesis about outcomes. The study will enroll up to 300 patients from sites in the EU and other select regions who have upper lobe predominant emphysema and are prescribed BTVA. After treatment with the InterVapor device, patients will be followed according to standard care practices for five years. Data collected will include lung function tests, exercise capacity, imaging results, and quality of life questionnaires. The registry also records all adverse events and has an independent monitor to assess serious event relatedness. Participants will undergo routine assessments including spirometry, body plethysmography, diffusing capacity for carbon monoxide, six-minute walk tests, chest X-rays, and CT scans. Quality of life will be tracked using a questionnaire over the five-year follow-up. Safety data and lung volume changes will be reviewed regularly. The study will summarize these data using descriptive statistics to provide a comprehensive picture of patient outcomes after BTVA treatment.

Post-Market BTVA Registry