Actively Recruiting
Pilot Study of Endobronchial Thermal Liquid Ablation ETLA for Treating Severe Emphysema in Adults 40 and Older
Led by Morair Medtech, LLC · Updated on 2025-01-28
30
Participants Needed
7
Research Sites
12 weeks
Total Duration
AI-Summary
What this Trial Is About
The trial investigates the use of endobronchial thermal liquid ablation ETLA for treating severe emphysema, focusing on feasibility and safety. ETLA aims to reduce lung volume by delivering heated saline to damaged lung areas, potentially improving lung function and quality of life for patients with severe emphysema. This pilot study is sponsored by Morair Medtech, LLC, and evaluates both safety and effectiveness of the treatment. Participants will receive up to two ETLA procedures under general anesthesia, with at least a three-month gap between treatments. Each procedure targets one lung, either unilaterally or bilaterally over two sessions. The study includes five in-person clinic visits and two virtual follow-ups to monitor progress and safety. Throughout the study, participants will undergo assessments such as lung function tests, walking distance tests, and quality of life questionnaires at multiple time points up to nine months. Researchers will track device performance, adverse events, and lung volume changes to evaluate treatment impact and safety. The total monitoring period includes up to nine months of follow-up after procedures to ensure comprehensive data collection and participant safety.
CONDITIONS
Brief Title
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
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