RecruitingNot ApplicableNCT06655428

The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema

The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)


Sponsor

Morair Medtech, LLC

Enrollment

30 participants

Start Date

Jan 10, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety. Participants will: * Have up to two ETLA procedures * Complete five clinic follow-up visits and two virtual follow-up visits.


Eligibility

Min Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study (REDUCE EU) is testing a bronchoscopic procedure called Endobronchial Thermal Liquid Ablation (ETLA) — a minimally invasive lung treatment delivered through a breathing tube — to reduce the size of overinflated lung areas in patients with severe emphysema (a type of advanced COPD where air becomes trapped in the lungs). **You may be eligible if...** - You are 40 or older with a confirmed COPD diagnosis - Breathing tests show your lung function is between 20–49% of normal, with significant air trapping and overinflation - You can walk at least 140 meters in a 6-minute walk test - You have shortness of breath even with activity - You have been on optimized COPD medications and have not smoked for at least 3 months - You are doing regular physical exercise beyond daily activities **You may NOT be eligible if...** - You have recently had a COPD flare-up or lung infection - You are a current smoker - Your lung function is outside the specified range - You have certain other lung or cardiovascular conditions Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEndobronchial Therman Liquid Ablation (ETLA)

The ETLA System is a minimally invasive bronchoscopic treatment designed to deliver heated normal saline to targeted emphysematous lung regions with hyperinflation to cause tissue ablation and subsequent volume reduction as a means for treating emphysema. The ETLA procedures will be performed under general anesthesia. Each procedure will be limited to treatment in a single lung, with either unilateral or bilateral treatment over the two procedures.


Locations(7)

Universitätsklinikum Allgemeines Krankenhaus Wien

Vienna, Austria, Austria

Klinik Floridsdorf

Vienna, Austria, Austria

Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin

Berlin, Germany, Germany

Asklepios Lungenklinik Gauting GmbH

Gauting, Germany, Germany

Asklepios Klinik Barmbek

Hamburg, Germany, Germany

Thoraxklinik University of Heidelberg

Heidelberg, Germany, Germany

University Medical Center Groningen

Groningen, The Netherlands, Netherlands

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NCT06655428


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