Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
Study NCT ID:
NCT05118269
Status:
TERMINATED
Last Update Posted:
2025-02-27
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
Sponsor:
Uptake Medical Technology, Inc.
Organization:
Study Overview
Official Title:
Targeted Segmental Vapor Ablation Treatment of Emphysema With Upper Lobe Predominance: A Randomized Controlled Trial of InterVapor® in France - The TARGET Trial
Status:
TERMINATED
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
The sponsor made the decision not to conduct this study. No subjects were treated in the study and all centers closed.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is designed to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with InterVapor® in patients with heterogeneous emphysema with upper lobe predominance. For validity of the study, the results will be compared to patients that receive optimal medical therapy.
Detailed Description:
The primary objectives are to prospectively document changes in FEV1 and health-related quality of life 12 months following sequential segmental treatment with Bronchoscopic Thermal Vapor Ablation (BTVA) using the InterVapor system in patients with heterogeneous emphysema with upper lobe predominance. The French TARGET trial is a prospective, multi-center, single blind, randomized controlled study. 150 participants will be enrolled in the study (1:1 randomization with 75 InterVapor, 75 controls) with a 24-month follow-up period. Subjects randomized to the Control Group may be allowed to cross over to the treatment group and offered the InterVapor treatment once they have completed the protocol defined 12-month follow-up period.
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?: