BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorIHF GmbH - Institut für Herzinfarktforschung
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Age: ≥ 40 years and ≤ 75 years
Written informed consent obtained from the patient
bilateral heterogeneous emphysema of the upper lobes in GOLD stage 3/4 and
evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and
Disqualifiers
Any condition that would interfere with the conduct of the clinical trial follow-up or bronchoscopy or affect the outcome of the clinical trial
DLCO < 20% (calculated)
Body mass index (BMI) < 18 kg/m2 or > 32 kg/m2
Pulmonary hypertension
Trial design
Design model
Parallel
Treatments tested in this trial
InterVapor®-System
DeviceThe 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.
Treatment groups
224 Participants
are divided into 2 treatment groupsGroup A: InterVapor®-SystemActive comparator 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
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 monthsSecondary outcomes
1
Vital status
alive/dead
Time frame
3, 9 and 12 months2
Change in FEV 1
Change in forced expiratory pressure (FEV 1) in litres and percent
Time frame
3, 9 and 12 months3
Change in RV
Change in residual volume in litre and percent.
Time frame
3, 9 and 12 months4
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
3, 9 and 12 monthsSponsors and contacts
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Source ClinicalTrials.gov