Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03360396
Status:
COMPLETED
Last Update Posted:
2023-08-28
First Post:
2017-11-22
Brief Title:
Study of PneumRx Endobronchial Coil System in Treatment of Subjects With Severe Emphysema
Sponsor:
Boston Scientific Corporation
Organization:
Boston Scientific Corporation
Study Overview
Official Title:
A Randomized Controlled Study of PneumRx Endobronchial Coil System Versus Standard-of-Care Medical Management in the Treatment of Subjects With Severe Emphysema
Status:
COMPLETED
Status Verified Date:
2023-08
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:
ELEVATE
Brief Summary:
This study will look at outcomes between Endobronchial Coil Treatment and Control groups in patients with severe heterogeneous and or homogeneous emphysema
Detailed Description:
This will be a prospective multicenter randomized controlled study comparing outcomes between the Endobronchial Coil and Control Groups Subjects will be block randomized in a Treatment to Control ratio of 21 The randomization will be stratified by site and homogeneous versus heterogeneous emphysema to support a balance of patients with differing heterogeneity in both the Treatment and Control Groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None