Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation

Status: Recruiting
Location: See all (12) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 75
Healthy Volunteers: f
View:

• 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).

Locations
Other Locations
Germany
Charité Campus Benjamin Franklin
RECRUITING
Berlin
Gemeinschaftskrankenhaus Havelhöhe gGmbH Klinik für Anthroposophische Medizin
RECRUITING
Berlin
Universitätsklinikum Bonn, Medizinische Klinik und Poliklinik II
NOT_YET_RECRUITING
Bonn
Pneumologische Universitätsklinik Ruhrlandklinik
RECRUITING
Essen
Universitätsklinikum Halle (Saale)
RECRUITING
Halle
Thoraxklinik University of Heidelberg
RECRUITING
Heidelberg
Lungenklinik Hemer
RECRUITING
Hemer
Lungenfachklinik Immenhausen
RECRUITING
Immenhausen
Asklepios Klinik Langen, Klinik für Innere Medizin III
NOT_YET_RECRUITING
Langen
KlinKlinikuim Lüdenscheid, Klinik für Pneumologie, internistische Intensivmedizin, Infektiologie und Schlafmedizin
RECRUITING
Lüdenscheid
Thoraxzentrum Bezirk Unterfranken
RECRUITING
Münnerstadt
Helios Hanseklinikum Stralsund
RECRUITING
Stralsund
Contact Information
Primary
Felix Herth, MD
felix.herth@med.uni-heidelberg.de
+49 6221 396 1200
Backup
Leschek Brachmann, Masters of Science
leschek.brachmann@ihf.de
+49 621 59577 225
Time Frame
Start Date: 2024-04-24
Estimated Completion Date: 2027-12-01
Participants
Target number of participants: 224
Treatments
Active_comparator: InterVapor®-System
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
No_intervention: Standard of care
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).
Sponsors
Leads: IHF GmbH - Institut für Herzinfarktforschung

This content was sourced from clinicaltrials.gov