Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-07 @ 9:19 AM
Study NCT ID:
NCT02059057
Status:
TERMINATED
Last Update Posted:
2021-07-19
First Post:
2014-02-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LVRC IDE Crossover Study (Crossover From IDE Trial CLN0009)
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Crossover From IDE Trial CLN0009, Lung Volume Reduction Coil Treatment in Patients With Emphysema (RENEW) Study, IDE G110066
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA approval of supplementation to IDE/protocol amendment to terminate subject long term follow up
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CROSSOVER
Brief Summary:
Crossover study for patients who were randomized to the Control Group in CLN0009 (NCT01608490).
Detailed Description:
Provide LVRC procedure to qualifying subjects who were enrolled as Control Subjects in and completed the Lung Volume Reduction Coil Treatment in Patients with Emphysema (RENEW) Study, CLN0009, and obtain safety and effectiveness data on these patients.
Study Oversight
Has Oversight DMC:
True
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?: