Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-02-20 @ 11:32 AM
Study NCT ID:
NCT02068768
Status:
TERMINATED
Last Update Posted:
2019-07-05
First Post:
2014-02-19
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation
Sponsor:
LDR Spine USA
Organization:
Study Overview
Official Title:
A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation
Status:
TERMINATED
Status Verified Date:
2019-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Poor enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: