Emphysema or Chronic Obstructive Pulmonary DiseaseNCT05717192
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
A study testing InterVapor®-System in people with Emphysema or Chronic Obstructive Pulmonary Disease, run by IHF GmbH - Institut für Herzinfarktforschung at 12 sites in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Emphysema or Chronic Obstructive Pulmonary Disease
- What is being tested?
- InterVapor®-System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 12 sitesGermany
- Study dates
- 24 Apr 2024to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 21Show fewer
- 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).
Who cannot join
- 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
Show all 28Show fewer
- 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
Trial locations and contacts
12 sites in 1 country. Contact the study team or a site near you to ask about taking part.
12 sites in 1 country
Germany12 sites, 12 recruiting
- Recruiting
Charité Campus Benjamin Franklin
Berlin, 13353
Ralf-Harto Hübner, Dr. med., 0049 30-450 653787, ralf-harto.huebner@charite.de
Ralf-Harto Hübner, Dr.
- Recruiting
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
Berlin, 14089
Hannah Wüstefeld, Dr. med., 0049 30 365 280, lunge@havelhoehe.de
Christian Grah, Dr. med., christian.grah@havelhoehe.de
- Not yet recruiting
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
Bonn, 53127
Dirk Skowasch, Prof., +49 228-287-16670, dirk.skowasch@ukbonn.de
Dirk Skowasch, Prof.
- Recruiting
Pneumologische Universitätsklinik Ruhrlandklinik
Essen, 4542329
Rüdiger Karpf-Wissel, Dr., 0049 201/ 433 4222, Ruediger.Karpf-Wissel@rlk.uk-essen.de
Rüdiger Karpf-Wissel, Dr.
- Recruiting
Universitätsklinikum Halle (Saale)
Halle, 06120
Stephan Eisenmann, Dr., +49 345 5573238, stephan.eisenmann@uk-halle.de
Stephan Eisenmann, Dr.
- Recruiting
Thoraxklinik University of Heidelberg
Heidelberg, 69126
Felix Herth, Prof. Dr., +49 6221 396 1200, felix.herth@med.uni-heidelberg.de
Felix Herth, Prof. Dr.
- Recruiting
Lungenklinik Hemer
Hemer, 58675
Kaid Darwiche, Prof. Dr., +49 2372 908 2179, kaid.darwiche@lkhemer.de
Birte Schwarz, +49 2372-908-2179, Birte.Schwarz@lkhemer.de
- Recruiting
Lungenfachklinik Immenhausen
Immenhausen, 34376
Peter Hammerl, Dr. med., +49 5673 501 1501, hammerl@lungenfachklinik-immenhausen.de
Peter Hammerl, Dr. med.
- Not yet recruiting
Asklepios Klinik Langen, Klinik für Innere Medizin III
Langen, 63225
Michael Bender, Dr. med., +49 6103 912 61480, mi.bender@asklepios.com
Thorsten Stein, Dr. med., th.stein@asklepios.com
- Recruiting
KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin
Lüdenscheid, 58515
Wolfgang Hohenforst-Schmidt, Dr. med., +49 2351 46-66225, pneumologie@klinikum-luedenscheid.de
Wolfgang Hohenforst-Schmidt, Dr. med.
- Recruiting
Thoraxzentrum Bezirk Unterfranken
Münnerstadt, 97702
Bernd Seese, Dr., 0049 9733/62-3700, b.seese@tzbu.de
Bernd Seese, Dr.
- Recruiting
Helios Hanseklinikum Stralsund
Stralsund, 18435
Tom Bollmann, Dr. med., +49 3831352588, tom.bollmann@helios-gesundheit.de
Tom Bollmann, Dr. med.
About this study
Official title: Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
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).
Read the 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.
- Being tested
- InterVapor®-System
- Medical subject headings
- Emphysema, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InterVapor®-SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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). |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 9 months
Secondary outcomes (8)
Vital status
alive/dead
Measured: 3, 9 and 12 months
Change in FEV 1
Change in forced expiratory pressure (FEV 1) in litres and percent
Measured: 3, 9 and 12 months
Change in RV
Change in residual volume in litre and percent.
Measured: 3, 9 and 12 months
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.
Measured: 3, 9 and 12 months
Serious Adverse Events
Rate of serious adverse events
Measured: 3, 9 and 12 months
6-minute walk test (6MWT)
Measures the distance (meter) in a 6-minute walk test.
Measured: 3, 9 and 12 months
Severe excacerbations
Rate of severe exacerbations
Measured: 3, 9 and 12 months
Mortality
All-cause mortality
Measured: 3, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2023
- Study start24 Apr 2024
- Primary completion25 Apr 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Emphysema or Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IHF GmbH - Institut für Herzinfarktforschung
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05717192
- Sponsor's protocol ID
- MDR-0002
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2022
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 38806430
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
- ClinicalTrials.gov ID
- NCT05717192
- Acronym / sponsor ID
- MDR-0002
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- IHF GmbH - Institut für HerzinfarktforschungUniversity, hospital or other
- Study start
- 24 Apr 2024 (actual)
- Primary completion
- 25 Apr 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| InterVapor®-System | Active comparator | Device: InterVapor®-SystemThe 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 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). |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (28 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| InterVapor®-SystemThe 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. | Device | InterVapor®-System |
Primary outcome
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.
8 secondary outcomes
Vital status
Time frame: 3, 9 and 12 months
Change in FEV 1
Time frame: 3, 9 and 12 months
Change in RV
Time frame: 3, 9 and 12 months
Change in patient-reported, disease-specific quality of life
Time frame: 3, 9 and 12 months
Serious Adverse Events
Time frame: 3, 9 and 12 months
6-minute walk test (6MWT)
Time frame: 3, 9 and 12 months
Severe excacerbations
Time frame: 3, 9 and 12 months
Mortality
Time frame: 3, 9 and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2025.
- Derived from this study: PubMed 38806430Kontogianni 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.
- Individual participant dataSharing planned: No. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing InterVapor®-System in people with Emphysema or Chronic Obstructive Pulmonary Disease, run by IHF GmbH - Institut für Herzinfarktforschung at 12 sites in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Felix Herth, MD (+49 6221 396 1200, felix.herth@med.uni-heidelberg.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient-reported disease-specific quality of life (time frame: 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05717192, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2025.