Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-26 @ 2:11 AM
Study NCT ID:
NCT01461005
Status:
TERMINATED
Last Update Posted:
2020-02-19
First Post:
2011-10-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System (DSS)
Sponsor:
Paradigm Spine
Organization:
Study Overview
Official Title:
A Postmarket Surveillance Study of the Paradigm Spine Dynamic Stabilization System(DSS)
Status:
TERMINATED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
FDA reclassified so all 522 studies were stopped,
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DSS
Brief Summary:
The purpose of the Post-Market Surveillance study is to evaluate safety.
Detailed Description:
Paradigm Spine Dynamic Stabilization System (DSS) study is a prospective, multi-center, literature controlled study.
Study Oversight
Has Oversight DMC:
False
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?: