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BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Sponsor: IHF GmbH - Institut für Herzinfarktforschung
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).
Official title: Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Key Details
Gender
All
Age Range
40 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
224
Start Date
2024-04-24
Completion Date
2027-12-01
Last Updated
2025-08-24
Healthy Volunteers
No
Interventions
InterVapor®-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