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).
Currently, there is less data on the use of bronchoscopic thermoablation (BTVA) for the treatment of patients with emphysema. However, the current studies suggest with a high degree of certainty that bronchoscopic lung volume reduction for severe emphysema using thermoablation has the potential to be a necessary treatment alternative. The trial study should therefore contribute to proving the benefit of this procedure as an effective and safe treatment option in order to guarantee emphysema patients sufficient, appropriate and economical care, taking into account evidence-based medical knowledge.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
224
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.
Charité Campus Benjamin Franklin
Berlin, Germany
RECRUITINGGemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany
Change in patient-reported disease-specific quality of life
Change in patient-reported, disease-specific quality of life based on St. George's Respiratory Questionnaire (SGRQ-C) between randomisation and 9-month visit. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
Time frame: 9 months
Vital status
alive/dead
Time frame: 3, 9 and 12 months
Change in FEV 1
Change in forced expiratory pressure (FEV 1) in litres and percent
Time frame: 3, 9 and 12 months
Change in RV
Change in residual volume in litre and percent.
Time frame: 3, 9 and 12 months
Change in patient-reported, disease-specific quality of life
Change in patient-reported, disease-specific quality of life based on St. George's Respiratory Questionnaire (SGRQ-C) between randomisation and 9-month visit. The instrument has 3 domains (activity, symptoms, and impacts) and a total score. A Total and three-component scores are calculated: Symptoms; Activity; Impacts. Each questionnaire response has a unique empirically derived 'weight'. The lowest possible weight is zero and the highest is 100. Each component of the questionnaire is scored separately. Sum of maximum possible weights for each component and Total: Symptoms 566.2, Activity 982.9, Impacts 1652.8. Total (sum of maximum for all three components) 3201.9 Higher weights indicate worse outcomes. The difference in the domain scores and total score at follow-up visits relative to baseline will be calculated and reported.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
Bonn, Germany
NOT_YET_RECRUITINGPneumologische Universitätsklinik Ruhrlandklinik
Essen, Germany
RECRUITINGUniversitätsklinikum Halle (Saale)
Halle, Germany
RECRUITINGThoraxklinik University of Heidelberg
Heidelberg, Germany
RECRUITINGLungenklinik Hemer
Hemer, Germany
RECRUITINGLungenfachklinik Immenhausen
Immenhausen, Germany
RECRUITINGAsklepios Klinik Langen, Klinik für Innere Medizin III
Langen, Germany
NOT_YET_RECRUITINGKlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin
Lüdenscheid, Germany
RECRUITING...and 2 more locations
Time frame: 3, 9 and 12 months
Serious Adverse Events
Rate of serious adverse events
Time frame: 3, 9 and 12 months
6-minute walk test (6MWT)
Measures the distance (meter) in a 6-minute walk test.
Time frame: 3, 9 and 12 months
Severe excacerbations
Rate of severe exacerbations
Time frame: 3, 9 and 12 months
Mortality
All-cause mortality
Time frame: 3, 9 and 12 months