Ignite Creation Date:
2024-05-06 @ 12:33 AM
Last Modification Date:
2024-10-26 @ 10:52 AM
Study NCT ID:
NCT01608490
Status:
TERMINATED
Last Update Posted:
2021-07-19
First Post:
2012-05-26
Brief Title:
Lung Volume Reduction Coil Treatment in Patients With Emphysema RENEW Study
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
Lung Volume Reduction Coil Treatment in Patients With Emphysema RENEW Study
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA approval of supplementation to IDE 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:
RENEW
Brief Summary:
Multicenter randomized assessor-blinded controlled study of safety and effectiveness of the PneumRx Inc RePneu Lung Volume Reduction Coil RePneu LVRC System
Detailed Description:
This will be a prospective multicenter randomized assessor-blinded controlled study comparing outcomes between the LVRC and Control Groups Subjects will be block randomized in an LVRC Treatment to Control ratio of 11 The randomization will be stratified by homogeneous versus heterogeneous emphysema to support a balance of patients with differing heterogeneity in both the LVRC and Control Groups
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