BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-75
SponsorIHF GmbH - Institut für Herzinfarktforschung
About this trial
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).
Eligibility criteria
Qualifiers
Age: ≥ 40 years and ≤ 75 years
Written informed consent obtained from the patient
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- InterVapor®-System
Treatment groups
224 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov