Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-27 @ 5:48 AM
Study NCT ID:
NCT04563793
Status:
COMPLETED
Last Update Posted:
2025-01-13
First Post:
2020-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Sponsor:
Boston Scientific Corporation
Organization:
Study Overview
Official Title:
Postmarket Outcomes Study for Evaluation of the Superion™ Spacer
Status:
COMPLETED
Status Verified Date:
2024-09
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:
PRESS2
Brief Summary:
To compile real-world outcomes of the Superion™ IDS in routine clinical practice.
Detailed Description:
The purpose of this outcomes study is to compile real-world outcomes for the commercially approved Indirect Decompression Systems (IDS) in routine clinical practice when used according to the applicable Instructions for Use.
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: