BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

NCT05717192 | Recruiting DMC

• 1 other identifier: MDR-0002
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 12

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).

Conditions

Emphysema or Chronic Obstructive Pulmonary Disease

Outcome Measures

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.

  9 months

Secondary Outcomes (8)

• Vital status

  3, 9 and 12 months

• Change in FEV 1

  3, 9 and 12 months

• Change in RV

  3, 9 and 12 months

• Change in patient-reported, disease-specific quality of life

  3, 9 and 12 months

• Serious Adverse Events

  3, 9 and 12 months

Study Arms (2)

InterVapor®-System

ACTIVE COMPARATOR

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

Device: InterVapor®-System

Standard of care

NO INTERVENTION

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).

Interventions

InterVapor®-System 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.

InterVapor®-System

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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
• minute walk test \> 140 metres
• Patient-specific, pre-interventional exhaustion of conservative treatment options
• optimised medical therapy (according to the GOLD guidelines) and
• Evidence of completed pulmonary and geriatric rehabilitation in the last 4 years
• ≥ 6 weeks outpatient or

You may not qualify if:

• 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

Sponsors & Collaborators

• IHF GmbH - Institut für Herzinfarktforschung: lead

Study Sites (12)

Charité Campus Benjamin Franklin

Berlin, 13353, Germany

RECRUITING

Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin

Berlin, 14089, Germany

RECRUITING

Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II

Bonn, 53127, Germany

NOT YET RECRUITING

Pneumologische Universitätsklinik Ruhrlandklinik

Essen, 4542329, Germany

RECRUITING

Universitätsklinikum Halle (Saale)

Halle, 06120, Germany

RECRUITING

Thoraxklinik University of Heidelberg

Heidelberg, 69126, Germany

RECRUITING

Lungenklinik Hemer

Hemer, 58675, Germany

RECRUITING

Lungenfachklinik Immenhausen

Immenhausen, 34376, Germany

RECRUITING

Asklepios Klinik Langen, Klinik für Innere Medizin III

Langen, 63225, Germany

NOT YET RECRUITING

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

Lüdenscheid, 58515, Germany

RECRUITING

Thoraxzentrum Bezirk Unterfranken

Münnerstadt, 97702, Germany

RECRUITING

Helios Hanseklinikum Stralsund

Stralsund, 18435, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 38806430 DERIVED

MeSH Terms

Conditions

Emphysema; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes

Central Study Contacts

Felix Herth, MD

CONTACT

+49 6221 396 1200; felix.herth@med.uni-heidelberg.de

Leschek Brachmann, Masters of Science

CONTACT

+49 621 59577 225; leschek.brachmann@ihf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: February 8, 2023
• Study Start: April 24, 2024
• Primary Completion: April 25, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: August 24, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (12)