BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

IHF GmbH - Institut für Herzinfarktforschung

Status: Enrolling

Conditions: Emphysema or Chronic Obstructive Pulmonary Disease

Treatments: Device: InterVapor®-System

Study type: Interventional

Funder types: Other

Identifiers

NCT05717192

MDR-0002

Details and patient eligibility

About

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).

Full 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.

Enrollment: 224 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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 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-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).

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, 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 design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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224 participants in 2 patient groups

InterVapor®-System

Active Comparator group

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

Treatment:

Device: InterVapor®-System

Standard of care

No Intervention group

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).