BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

NCT ID: NCT05717192

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 224 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-24
• Study Completion Date: 2027-12-01

Brief 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).

Detailed Description

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.

Conditions

Emphysema or Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

InterVapor®-System

The intervention to be tested is bronchoscopic lung volume reduction (BTVA) using thermal ablation (InterVapor®, Uptake Medical, California, USA). This is performed in addition to standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines. The intervention can consist of a maximum of two partial interventions

Group Type: ACTIVE_COMPARATOR

InterVapor®-System

Intervention Type: DEVICE

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.

Standard of care

Standard conservative therapy in accordance with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines without the use of a BTVA (patient-specific documentation of therapeutic measures).

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age: ≥ 40 years and ≤ 75 years
• Written informed consent obtained from the patient
• Severe emphysema with indication for BTVA:
• 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
• functional evidence of severe pulmonary hyperinflation and
• FEV1 post lysis between 20% and < 45% (calculated) and
• Total lung capacity (TLC) ≥ 100% (calculated) and
• Residual volume (RV) > 175% (calculated) and
• arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 > 50 mmHg on room air and
• marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC) and
• 6-minute walk test > 140 metres
• Patient-specific, pre-interventional exhaustion of conservative treatment options
• optimised medical therapy (according to the GOLD guidelines) and
• Non-smoker for 6 months prior to inclusion
• Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years
• ≥ 6 weeks outpatient or
• ≥ 3 weeks inpatient or
• Individual Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)
• According to the investigator's assessment mentally and physically able to participate in the study procedures and visits
• Indication within the framework of an interdisciplinary case conference with specialists in pneumology, radiology and thoracic surgery in accordance with §3 of the guideline on quality assurance measures in accordance with § 136 Paragraph 1 Sentence 1 Number 2 SGB V for inpatient care with bronchoscopic lung volume reduction procedures for severe emphysema (QS-RL BLVR).

Exclusion Criteria

• 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
• Peak systolic PAP > 45 mmHg or mean PAP > 25 mmHg
• Right heart catheter measurements are considered authoritative over echocardiogram measurements
• Clinically significant bronchiectasis
• Pneumothorax or pleural effusions within the last 6 months
• Heart and/or lung transplantation, surgical lung volume reduction (LVRS), bullectomy, lobectomy or pneumonectomy, pleurodesis or any surgery in the target lobes (upper lobes).
• Recent respiratory infection or COPD exacerbation in the last 6 weeks
• Unstable COPD (any of the following conditions):
• >3 COPD-related hospitalisations requiring antibiotics in the last 12 months
• COPD-related hospital stay in the last 3 months
• daily use of systemic steroids, > 5 mg prednisolone
• Single large bulla (defined as > 1/3 of the volume of the lobe) in the upper lobe or paraseptal emphysema distribution in the lobe being treated
• Coagulopathy or current use of anticoagulants
• Patients with current endobronchial valves or with valves explanted less than 6 months ago in the target lobe in a segment to be treated with InterVapor®.
• Patients with implanted, endobronchial coils (coils)
• Patients with previous endobronchial polymer/adhesive treatment
• Patients with immune system disorders or concomitant diseases that necessitate the use of immunosuppressants of clinical relevance
• History of any of the following conditions:
• Myocardial infarction or acute coronary syndrome in the previous year
• Hospitalisation for left heart failure in the last year
• clinically leading asthma disease or alpha-1-antitrypsin deficiency
• Known sensitivity to medications required to perform bronchoscopy
• Life expectancy < 12 months
• Newly prescribed morphine derivatives within the last 4 weeks
• Pregnancy at the time of inclusion

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IHF GmbH - Institut für Herzinfarktforschung

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Charité Campus Benjamin Franklin

Berlin, , Germany

Site Status: RECRUITING

Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin

Berlin, , Germany

Site Status: RECRUITING

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, , Germany

Site Status: NOT_YET_RECRUITING

Pneumologische Universitätsklinik Ruhrlandklinik

Essen, , Germany

Site Status: RECRUITING

Universitätsklinikum Halle (Saale)

Halle, , Germany

Site Status: RECRUITING

Thoraxklinik University of Heidelberg

Heidelberg, , Germany

Site Status: RECRUITING

Lungenklinik Hemer

Hemer, , Germany

Site Status: RECRUITING

Lungenfachklinik Immenhausen

Immenhausen, , Germany

Site Status: RECRUITING

Asklepios Klinik Langen, Klinik für Innere Medizin III

Langen, , Germany

Site Status: NOT_YET_RECRUITING

KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin

Lüdenscheid, , Germany

Site Status: RECRUITING

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, , Germany

Site Status: RECRUITING

Helios Hanseklinikum Stralsund

Stralsund, , Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Felix Herth, MD

Role: CONTACT

felix.herth@med.uni-heidelberg.de

+49 6221 396 1200

Leschek Brachmann, Masters of Science

Role: CONTACT

leschek.brachmann@ihf.de

+49 621 59577 225

Facility Contacts

Ralf-Harto Hübner, Dr. med.

Role: primary

ralf-harto.huebner@charite.de

0049 30-450 653787

Hannah Wüstefeld, Dr. med.

Role: primary

lunge@havelhoehe.de

0049 30 365 280

Christian Grah, Dr. med.

Role: backup

christian.grah@havelhoehe.de

Dirk Skowasch, Prof.

Role: primary

dirk.skowasch@ukbonn.de

+49 228-287-16670

Rüdiger Karpf-Wissel, Dr.

Role: primary

Ruediger.Karpf-Wissel@rlk.uk-essen.de

0049 201/ 433 4222

Stephan Eisenmann, Dr.

Role: primary

stephan.eisenmann@uk-halle.de

+49 345 5573238

Felix Herth, Prof. Dr.

Role: primary

felix.herth@med.uni-heidelberg.de

+49 6221 396 1200

Kaid Darwiche, Prof. Dr.

Role: primary

kaid.darwiche@lkhemer.de

+49 2372 908 2179

Birte Schwarz

Role: backup

Birte.Schwarz@lkhemer.de

+49 2372-908-2179

Peter Hammerl, Dr. med.

Role: primary

hammerl@lungenfachklinik-immenhausen.de

+49 5673 501 1501

Michael Bender, Dr. med.

Role: primary

mi.bender@asklepios.com

+49 6103 912 61480

Thorsten Stein, Dr. med.

Role: backup

th.stein@asklepios.com

Wolfgang Hohenforst-Schmidt, Dr. med.

Role: primary

pneumologie@klinikum-luedenscheid.de

+49 2351 46-66225

Bernd Seese, Dr.

Role: primary

b.seese@tzbu.de

0049 9733/62-3700

Tom Bollmann, Dr. med.

Role: primary

tom.bollmann@helios-gesundheit.de

+49 3831352588

References

Kontogianni K, Darwiche K, Huebner RH, Hassinger F, Riemer T, Herth FJ, Brock J. Design of the multicentre randomised controlled BENTO trial to demonstrate patient-relevant benefit of bronchoscopic lung volume reduction using thermal vapour ablation in the German healthcare system for patients with upper lobe emphysema: a study protocol. BMJ Open. 2024 May 28;14(5):e080518. doi: 10.1136/bmjopen-2023-080518.

Reference Type: DERIVED

PMID: 38806430 (View on PubMed)

Other Identifiers

MDR-0002

Identifier Type: -

Identifier Source: org_study_id