RecruitingNot ApplicableNCT05717192

BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation


Sponsor

IHF GmbH - Institut für Herzinfarktforschung

Enrollment

224 participants

Start Date

Apr 24, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

Prospective, 2-arm, randomised (2:1), multicentre, open-label clinical trial in patients with severe emphysema. The intervention arm will be treated with Bronchoscopic lung volume reduction in severe emphysema using thermoablation.The interventional treatment (bronchoscopic lung volume reduction) is compared with the usual conservative standard therapy (GOLD guidelines).


Eligibility

Min Age: 40 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a bronchoscopic procedure called thermal vapor ablation (BTVA) to reduce lung volume in people with severe emphysema (a form of advanced COPD). The treatment targets over-inflated areas of the upper lungs using steam delivered through a bronchoscope (a thin tube passed through the airways), without open surgery. **You may be eligible if...** - You are between 40 and 75 years old with severe emphysema, mainly in the upper lobes - Your lung function tests confirm severe hyperinflation and reduced breathing capacity - You have not smoked for at least 6 months - You have already completed pulmonary rehabilitation - You are significantly short of breath even with optimal medical treatment **You may NOT be eligible if...** - Your lung diffusion capacity (DLCO) is severely reduced (below 20%) - Your BMI is below 18 or above 32 - You have pulmonary hypertension or other significant lung or heart conditions - You have another major condition that would interfere with recovery 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

DEVICEInterVapor®-System

The InterVapor System uses heated water vapor to ablate the airways and parenchyma within targeted regions of the lung. Lung remodeling occurs after an initial localized inflammatory response and a subsequent healing and repair. The remodeling of the tissue results in reductions in tissue and air volume in the targeted regions of the lung. The remodeled lung tissue does not re-inflate as a result of collateral ventilation. The lung volume reduction of diseased hyper-inflated lung segments after InterVapor treatment is expected to increase elastic recoil by reducing the most compliant segments of the lung, decompressing segments of healthier lung allowing for alveolar recruitment, and improving the mechanical efficiency of the respiratory muscles. These mechanical changes are anticipated to improve pulmonary function, exercise capacity and quality of life.


Locations(12)

Charité Campus Benjamin Franklin

Berlin, Germany

Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin

Berlin, Germany

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, Germany

Pneumologische Universitätsklinik Ruhrlandklinik

Essen, Germany

Universitätsklinikum Halle (Saale)

Halle, Germany

Thoraxklinik University of Heidelberg

Heidelberg, Germany

Lungenklinik Hemer

Hemer, Germany

Lungenfachklinik Immenhausen

Immenhausen, Germany

Asklepios Klinik Langen, Klinik für Innere Medizin III

Langen, Germany

KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin

Lüdenscheid, Germany

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, Germany

Helios Hanseklinikum Stralsund

Stralsund, Germany

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NCT05717192