Ignite Creation Date:
2024-10-25 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655428
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation ETLA for the Treatment of Emphysema
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The REDUCE EU Study - Endobronchial Thermal Liquid Ablation ETLA for the Treatment of Emphysema - a Pilot Study CSP-12123
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None