Ignite Creation Date:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
Study NCT ID:
NCT06655428
Status:
RECRUITING
Last Update Posted:
2025-01-28
First Post:
2024-10-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema
Sponsor:
Morair Medtech, LLC
Organization:
Study Overview
Official Title:
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation (ETLA) for the Treatment of Emphysema - A Pilot Study (CSP-12123)
Status:
RECRUITING
Status Verified Date:
2025-01
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:
The goal of this clinical trial is to learn if bronchoscopic lung volume reduction with endobronchial thermal liquid ablation (ETLA) works to treat severe emphysema in terms of feasibility and safety.
Participants will:
* Have up to two ETLA procedures
* Complete five clinic follow-up visits and two virtual follow-up visits.
Participants will:
* Have up to two ETLA procedures
* Complete five clinic follow-up visits and two virtual follow-up visits.
Detailed Description:
ETLA offers the potential to result in significant lung volume reduction of hyperinflated emphysematous regions, providing clinically meaningful improvement in pulmonary function and quality of life to a broad population of patients with severe emphysema. The REDUCE EU Pilot study will primarily evaluate the feasibility and safety of ETLA treatment in patients with severe emphysema. Secondarily, the study will evaluate the efficacy of sequential ETLA treatment.
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CIV-24-04-046660 | OTHER | European Commission | View |