BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
IHF GmbH - Institut für Herzinfarktforschung
224 participants
Apr 24, 2024
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
Plain Language Summary
Simplified for easier understanding
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Interventions
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)
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NCT05717192