Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2026-06-17 @ 7:35 PM
Study NCT ID:
NCT03247166
Status:
UNKNOWN
Last Update Posted:
2017-08-11
First Post:
2017-08-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Sponsor:
Hillel Yaffe Medical Center
Organization:
Study Overview
Official Title:
A Study to Evaluate the Safety and Effectiveness of the TOPS™ SP System
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
NOT_YET_RECRUITING
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:
The TOPS™ SP System is intended to provide stabilization in skeletally mature patients. The system is designed to afford motion of the spine segment without fusion. The pur0pose of this prospective clinical study is to establish the safety and effectiveness of the TOPS™ System, when used following decompression, in the treatment of lower back and sciatic pain.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: