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BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05717192
Recruitment Status : Not yet recruiting
First Posted : February 8, 2023
Last Update Posted : December 14, 2023
Sponsor:
Information provided by (Responsible Party):
IHF GmbH - Institut für Herzinfarktforschung

Study Description
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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).

Condition or disease Intervention/treatment Phase
Emphysema or Chronic Obstructive Pulmonary Disease Device: InterVapor®-System Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 224 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Estimated Study Start Date : January 1, 2024
Estimated Primary Completion Date : October 1, 2026
Estimated Study Completion Date : January 1, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Emphysema

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: 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
 Device: 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.
No Intervention: 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).


Outcome Measures
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Primary Outcome Measures :
  1. Change in patient-reported disease-specific quality of life [ Time Frame: 9 months ]

    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.



Secondary Outcome Measures :
  1. Vital status [ Time Frame: 3, 9 and 12 months ]
    alive/dead

  2. Change in FEV 1 [ Time Frame: 3, 9 and 12 months ]
    Change in forced expiratory pressure (FEV 1) in litres and percent

  3. Change in RV [ Time Frame: 3, 9 and 12 months ]
    Change in residual volume in litre and percent.

  4. Change in patient-reported, disease-specific quality of life [ Time Frame: 3, 9 and 12 months ]

    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.


  5. Serious Adverse Events [ Time Frame: 3, 9 and 12 months ]
    Rate of serious adverse events

  6. 6-minute walk test (6MWT) [ Time Frame: 3, 9 and 12 months ]
    Measures the distance (meter) in a 6-minute walk test.

  7. Severe excacerbations [ Time Frame: 3, 9 and 12 months ]
    Rate of severe exacerbations

  8. Mortality [ Time Frame: 3, 9 and 12 months ]
    All-cause mortality


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  • evidence of severe emphysema in high-resolution computed tomography
  • functional evidence of severe pulmonary hyperinflation
  • Collateral ventilation positive
  • FEV1 post lysis between 20% and < 45% (calculated)
  • Total lung capacity (TLC) ≥ 100% (calculated)
  • Residual volume (RV) > 175% (calculated)
  • arterial blood gas values of: PaCO2 ≤ 50 mmHg; PaO2 > 50 mmHg on room air.
  • marked dyspnoea with a score ≥ 2 on the Medical Research Council modified scale (mMRC).
  • 6-minute walk test > 140 metres
  • Patient-specific, pre-interventional exhaustion of conservative treatment options
  • optimised medical therapy (according to the GOLD guidelines)
  • 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
  • Participation in regular physical activities that go beyond the activities of daily living (e.g. a walking programme)
  • 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 or thoracic surgery with removal of lung tissue
  • 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 explanted valves in the target lobe with obvious airway obstruction 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05717192


Contacts
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Contact: Felix Herth, MD +49 6221 396 1200 felix.herth@med.uni-heidelberg.de
Contact: Nancy Hofmann +49 621 59577 214 hofmann@ihf.de

Locations
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Germany
Sozialstiftung Bamberg Klinikum am Bruderwald
Bamberg, Germany, 96049
Contact: Wolfgang Hohenforst-Schmidt, Dr. med.    49 951/503-15880    wolfgang.hohenforst-schmidt@sozialstiftung-bamberg.de   
Charité Campus Benjamin Franklin
Berlin, Germany, 13353
Contact: Ralf-Harto Hübner, Dr. med.    0049 30-450 653787    ralf-harto.huebner@charite.de   
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, Germany, 14089
Contact: Christian Grah, Dr.    0049 30 365 01 ext 280    christian.grah@havelhoehe.de   
Helios Klinikum Erfurt
Erfurt, Germany, 99089
Contact: Jens-Uwe Bauer, Dr. med.    + 49 361 781 - 2581    jens-uwe.bauer@helios-gesundheit.de   
Pneumologische Universitätsklinik Ruhrlandklinik
Essen, Germany, 4542329
Contact: Kaid Darwiche, Prof. Dr.    0049 201/ 433 4222    kaid.darwiche@rlk.uk-essen.de   
Asklepios Lungenklinik Gauting GmbH
Gauting, Germany, 82131
Contact: Wolfgang Gesierich, Dr. med.    0049 89 85791 ext 8116    w.gesierich@asklepios.com   
VAMED Klinik Hagen-Ambrock GmbH
Hagen, Germany, 58091
Contact: Wolfgang Galetke, Prof. Dr.    +49 02331 974 2000    wolfgang.galetke@vamed-gesundheit.de   
Universitätsklinikum Halle (Saale)
Halle, Germany, 06120
Contact: Stephan Eisenmann, Dr.    +49 345 5573238    stephan.eisenmann@uk-halle.de   
Asklepios Klinik Barmbek
Hamburg, Germany, 22307
Contact: Ralf Eberhardt, Prof. Dr.    +49 (040) 181882 ext 4800    r.eberhardt@asklepios.com   
Thoraxklinik University of Heidelberg
Heidelberg, Germany, 69126
Contact: Felix Herth, Prof. Dr.    +49 6221 396 1200    felix.herth@med.uni-heidelberg.de   
Lungenklinik Hemer
Hemer, Germany, 58675
Contact: Franz Stanzel, Dr. med.    +49 2372 908 2201    franz.stanzel@lkhemer.de   
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Contact: Peter Hammerl, Dr. med.    +49 5673 501 1501    hammerl@lungenfachklinik-immenhausen.de   
Universitätsklinikum Gießen und Marburg GmbH
Marburg, Germany, 35043
Contact: Angélique Holland, MD    +49 06421 - 5869608    holland@med.uni-marburg.de   
Helios Hanseklinikum Stralsund
Stralsund, Germany, 18435
Contact: Tom Bollmann, Dr. med.    +49 3831352588    tom.bollmann@helios-gesundheit.de   
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
Stuttgart, Germany, 70372
Contact: Martin Hetzel, Prof. Dr.    +49 711 5533-21111    Martin.Hetzel@Sana.de   
Rober-Bosch-Krankenhaus, Lungenzentrum
Stuttgart, Germany, 70376
Contact: Claus Neurohr, Prof. Dr.    +49 711 8101 ext 7201    claus.neurohr@rbk.de   
Sponsors and Collaborators
IHF GmbH - Institut für Herzinfarktforschung
More Information
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Responsible Party: IHF GmbH - Institut für Herzinfarktforschung
ClinicalTrials.gov Identifier: NCT05717192    
Other Study ID Numbers: MDR-0002
First Posted: February 8, 2023    Key Record Dates
Last Update Posted: December 14, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Data Sharing Processes

All subject-level clinical, laboratory, and quality of life data will be preserved and shared with the Sponsor via eCRF. Shared data will be deidentified and original data will be main-tained at the investigator's site. Study design, recruitment progress and final results will be documented at clinicaltrials.gov. The trial data will be passed on to the extent permitted by the patient´s informed consent. Upon completion of the study, individual participant data will not be made available on data sharing repositories.

The steering committee will decide on sharing study data upon reasonable request.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pulmonary Emphysema
Emphysema
Lung Diseases
 Respiratory Tract Diseases
Chronic Disease
Disease Attributes
Pathologic Processes