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BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Primary Purpose

Emphysema or Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
InterVapor®-System
Sponsored by
IHF GmbH - Institut für Herzinfarktforschung
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emphysema or Chronic Obstructive Pulmonary Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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

Sites / Locations

  • Sozialstiftung Bamberg Klinikum am Bruderwald
  • Charité Campus Benjamin Franklin
  • Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
  • Helios Klinikum Erfurt
  • Pneumologische Universitätsklinik Ruhrlandklinik
  • Asklepios Lungenklinik Gauting GmbH
  • VAMED Klinik Hagen-Ambrock GmbH
  • Universitätsklinikum Halle (Saale)
  • Asklepios Klinik Barmbek
  • Thoraxklinik University of Heidelberg
  • Lungenklinik Hemer
  • Lungenfachklinik Immenhausen
  • Universitätsklinikum Gießen und Marburg GmbH
  • Helios Hanseklinikum Stralsund
  • Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
  • Rober-Bosch-Krankenhaus, Lungenzentrum

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

InterVapor®-System

Standard of care

Arm Description

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

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).

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Vital status
alive/dead
Change in FEV 1
Change in forced expiratory pressure (FEV 1) in litres and percent
Change in RV
Change in residual volume in litre and percent.
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.
Serious Adverse Events
Rate of serious adverse events
6-minute walk test (6MWT)
Measures the distance (meter) in a 6-minute walk test.
Severe excacerbations
Rate of severe exacerbations
Mortality
All-cause mortality

Full Information

First Posted
December 19, 2022
Last Updated
February 6, 2023
Sponsor
IHF GmbH - Institut für Herzinfarktforschung
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1. Study Identification

Unique Protocol Identification Number
NCT05717192
Brief Title
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Official Title
Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2026 (Anticipated)
Study Completion Date
June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IHF GmbH - Institut für Herzinfarktforschung

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emphysema or Chronic Obstructive Pulmonary Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
224 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
InterVapor®-System
Arm Type
Active Comparator
Arm Description
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
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
InterVapor®-System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient-reported disease-specific quality of life
Description
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 months
Secondary Outcome Measure Information:
Title
Vital status
Description
alive/dead
Time Frame
3, 9 and 12 months
Title
Change in FEV 1
Description
Change in forced expiratory pressure (FEV 1) in litres and percent
Time Frame
3, 9 and 12 months
Title
Change in RV
Description
Change in residual volume in litre and percent.
Time Frame
3, 9 and 12 months
Title
Change in patient-reported, disease-specific quality of life
Description
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 months
Title
Serious Adverse Events
Description
Rate of serious adverse events
Time Frame
3, 9 and 12 months
Title
6-minute walk test (6MWT)
Description
Measures the distance (meter) in a 6-minute walk test.
Time Frame
3, 9 and 12 months
Title
Severe excacerbations
Description
Rate of severe exacerbations
Time Frame
3, 9 and 12 months
Title
Mortality
Description
All-cause mortality
Time Frame
3, 9 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Feilix Herth, MD
Phone
+49 6221 396 1200
Email
felix.herth@med.uni-heidelberg.de
First Name & Middle Initial & Last Name or Official Title & Degree
Nancy Hofmann
Phone
+49 621 59577 214
Email
hofmann@ihf.de
Facility Information:
Facility Name
Sozialstiftung Bamberg Klinikum am Bruderwald
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Hohenforst-Schmidt, Dr. med.
Phone
49 951/503-15880
Email
wolfgang.hohenforst-schmidt@sozialstiftung-bamberg.de
Facility Name
Charité Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf-Harto Hübner, Dr. med.
Phone
0049 30-450 653787
Email
ralf-harto.huebner@charite.de
Facility Name
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
City
Berlin
ZIP/Postal Code
14089
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christian Grah, Dr.
Phone
0049 30 365 01
Ext
280
Email
christian.grah@havelhoehe.de
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99089
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jens-Uwe Bauer, Dr. med.
Phone
+ 49 361 781 - 2581
Email
jens-uwe.bauer@helios-gesundheit.de
Facility Name
Pneumologische Universitätsklinik Ruhrlandklinik
City
Essen
ZIP/Postal Code
4542329
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaid Darwiche, Prof. Dr.
Phone
0049 201/ 433 4222
Email
kaid.darwiche@rlk.uk-essen.de
Facility Name
Asklepios Lungenklinik Gauting GmbH
City
Gauting
ZIP/Postal Code
82131
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Gesierich, Dr. med.
Phone
0049 89 85791
Ext
8116
Email
w.gesierich@asklepios.com
Facility Name
VAMED Klinik Hagen-Ambrock GmbH
City
Hagen
ZIP/Postal Code
58091
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wolfgang Galetke, Prof. Dr.
Phone
+49 02331 974 2000
Email
wolfgang.galetke@vamed-gesundheit.de
Facility Name
Universitätsklinikum Halle (Saale)
City
Halle
ZIP/Postal Code
06120
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephan Eisenmann, Dr.
Phone
+49 345 5573238
Email
stephan.eisenmann@uk-halle.de
Facility Name
Asklepios Klinik Barmbek
City
Hamburg
ZIP/Postal Code
22307
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ralf Eberhardt, Prof. Dr.
Phone
+49 (040) 181882
Ext
4800
Email
r.eberhardt@asklepios.com
Facility Name
Thoraxklinik University of Heidelberg
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felix Herth, Prof. Dr.
Phone
+49 6221 396 1200
Email
felix.herth@med.uni-heidelberg.de
Facility Name
Lungenklinik Hemer
City
Hemer
ZIP/Postal Code
58675
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Franz Stanzel, Dr. med.
Phone
+49 2372 908 2201
Email
franz.stanzel@lkhemer.de
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
ZIP/Postal Code
34376
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Hammerl, Dr. med.
Phone
+49 5673 501 1501
Email
hammerl@lungenfachklinik-immenhausen.de
Facility Name
Universitätsklinikum Gießen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angélique Holland, MD
Phone
+49 06421 - 5869608
Email
holland@med.uni-marburg.de
Facility Name
Helios Hanseklinikum Stralsund
City
Stralsund
ZIP/Postal Code
18435
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Bollmann, Dr. med.
Phone
+49 3831352588
Email
tom.bollmann@helios-gesundheit.de
Facility Name
Krankenhaus vom Roten Kreuz Bad Cannstatt GmbH
City
Stuttgart
ZIP/Postal Code
70372
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Hetzel, Prof. Dr.
Phone
+49 711 5533-21111
Email
Martin.Hetzel@Sana.de
Facility Name
Rober-Bosch-Krankenhaus, Lungenzentrum
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claus Neurohr, Prof. Dr.
Phone
+49 711 8101
Ext
7201
Email
claus.neurohr@rbk.de

12. IPD Sharing Statement

Learn more about this trial

BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

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