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New treatment option for Emphysema or Chronic Obstructive Pulmonary Disease
Official title BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
ClinicalTrials.gov ID: NCT05717192
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 75
You may be able to join 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
- evidence of severe emphysema in high-resolution computed tomography (not older than 6 months prior to inclusion) and
You likely can't join 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) \ 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
See the full eligibility 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-treatment 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...
- 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) \ 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
The study team makes the final eligibility decision.
Where it's taking place
- Berlin, Germany
- Bonn, Germany
- Essen, Germany
- Halle, Germany
- Heidelberg, Germany
- Hemer, Germany
- Immenhausen, Germany
- Langen, Germany
- Lüdenscheid, Germany
- Münnerstadt, Germany
- Stralsund, Germany
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Berlin, Germany; Bonn, Germany; Essen, Germany; Halle, Germany; Heidelberg, Germany; Hemer, Germany and 5 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.