Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-30 @ 8:40 AM
Study NCT ID:
NCT05717192
Status:
RECRUITING
Last Update Posted:
2025-08-24
First Post:
2022-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BENTO - Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Sponsor:
IHF GmbH - Institut für Herzinfarktforschung
Organization:
Study Overview
Official Title:
Bronchoscopic Lung Volume Reduction in Severe Emphysema Using Thermoablation
Status:
RECRUITING
Status Verified Date:
2024-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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).
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: