Actively Recruiting
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Led by IHF GmbH - Institut für Herzinfarktforschung · Updated on 2025-08-24
224
Participants Needed
12
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 40 and 75 years
- Written informed consent provided
- Severe emphysema with bilateral heterogeneous upper lobe disease in GOLD stage 3 or 4
- High-resolution CT showing severe emphysema within 6 months prior to inclusion
- Functional evidence of severe pulmonary hyperinflation
- Post-bronchodilator FEV1 between 20% and less than 45%
- Total lung capacity (TLC) equal or greater than 100%
- Residual volume (RV) greater than 175%
- Arterial blood gases with PaCO2 less than or equal to 50 mmHg and PaO2 greater than 50 mmHg on room air
- Dyspnea score of 2 or higher on the Medical Research Council modified scale (mMRC)
- Ability to walk more than 140 metres in 6 minutes
- Exhaustion of conservative treatment options before intervention
- Optimized medical therapy according to GOLD guidelines
- Non-smoker for at least 6 months prior to inclusion
- Completed pulmonary and geriatric rehabilitation within the last 4 years
- Participation in regular physical activities beyond daily living
- Mentally and physically able to participate in study procedures and visits
- Indication confirmed by interdisciplinary case conference with specialists
You will not qualify if you...
- Any condition interfering with trial follow-up, bronchoscopy, or affecting trial outcomes
- Diffusing capacity of the lungs for carbon monoxide (DLCO) less than 20%
- Body mass index (BMI) less than 18 or greater than 32 kg/m2
- Pulmonary hypertension with peak systolic PAP over 45 mmHg or mean PAP over 25 mmHg
- Clinically significant bronchiectasis
- Pneumothorax or pleural effusions in the last 6 months
- Previous lung surgeries in target lobes, including transplantation, lung volume reduction, bullectomy, lobectomy, pneumonectomy, or pleurodesis
- Respiratory infection or COPD exacerbation within the last 6 weeks
- Unstable COPD indicated by more than 3 hospitalizations requiring antibiotics in the past year, hospital stay in last 3 months, or daily use of systemic steroids over 5 mg prednisolone
- Single large bulla greater than one-third of lobe volume or paraseptal emphysema in target lobe
- Coagulopathy or current anticoagulant use
- Current or recent endobronchial valves, coils, or polymer/adhesive treatments in target lobe
- Immune system disorders requiring immunosuppressants
- Recent myocardial infarction or acute coronary syndrome within past year
- Hospitalization for left heart failure in past year
- Clinically leading asthma or alpha-1-antitrypsin deficiency
- Known sensitivity to bronchoscopy medications
- Life expectancy less than 12 months
- Newly prescribed morphine derivatives within last 4 weeks
- Pregnancy at time of inclusion
AI-Screening
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Trial Site Locations
Total: 12 locations
1
Charité Campus Benjamin Franklin
Berlin, Germany, 13353
Actively Recruiting
2
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany, 14089
Actively Recruiting
3
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
Bonn, Germany, 53127
Not Yet Recruiting
4
Pneumologische Universitätsklinik Ruhrlandklinik
Essen, Germany, 4542329
Actively Recruiting
5
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120
Actively Recruiting
6
Thoraxklinik University of Heidelberg
Heidelberg, Germany, 69126
Actively Recruiting
7
Lungenklinik Hemer
Hemer, Germany, 58675
Actively Recruiting
8
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Actively Recruiting
9
Asklepios Klinik Langen, Klinik für Innere Medizin III
Langen, Germany, 63225
Not Yet Recruiting
10
KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin
Lüdenscheid, Germany, 58515
Actively Recruiting
11
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, Germany, 97702
Actively Recruiting
12
Helios Hanseklinikum Stralsund
Stralsund, Germany, 18435
Actively Recruiting
Research Team
F
Felix Herth, MD
CONTACT
L
Leschek Brachmann, Masters of Science
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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