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RECRUITING
NCT05717192
NA

BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Sponsor: IHF GmbH - Institut für Herzinfarktforschung

View on ClinicalTrials.gov

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

DEVICE

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