Ignite Creation Date:
2025-12-25 @ 4:19 AM
Ignite Modification Date:
2026-02-25 @ 5:21 AM
Study NCT ID:
NCT02184520
Status:
TERMINATED
Last Update Posted:
2021-03-15
First Post:
2014-07-03
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Sponsor:
Globus Medical Inc
Organization:
Study Overview
Official Title:
A Prospective Randomized Postmarket Clinical Study of the TRANSITION Stabilization System
Status:
TERMINATED
Status Verified Date:
2021-02
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:
None
Brief Summary:
This postmarket surveillance study is being conducted to evaluate the TRANSITION Stabilization System as an adjunct to fusion in the treatment of acute or chronic instabilities or deformities of the thoracic, lumbar and sacral spine. The study will involve up to 360 subjects at no more than 20 sites, to be treated with the TRANSITION Stabilization System. The data from this postmarket surveillance study will be provided to FDA in accordance with the 522 order.
Detailed Description:
None
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?: