Ignite Creation Date:
2025-12-25 @ 12:33 AM
Ignite Modification Date:
2025-12-25 @ 10:41 PM
Study NCT ID:
NCT01433367
Status:
TERMINATED
Last Update Posted:
2025-12-24
First Post:
2011-06-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Clinical Trial Evaluating a Total Disc Replacement in Patients With Cervical Disc Disease
Sponsor:
NuVasive
Organization:
Study Overview
Official Title:
A Prospective Observational Study Evaluating the Performance of the CerPass® Total Disc Replacement in Patients With Single-Level Cervical Disc Disease
Status:
TERMINATED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Marketing of CE marked device has been discontinued.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CerPass
Brief Summary:
This study will be a non-randomized trial consisting of patients with single level (C3 to C7) symptomatic cervical disc disease who have not previously received fusion surgery at the same level, and have failed to improve with conservative treatment for at least 6 weeks prior to enrollment, or who present with progressive neurological symptoms or signs in the face of conservative treatment.
Detailed Description:
None
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?: