Ignite Creation Date:
2024-05-06 @ 6:32 PM
Last Modification Date:
2024-10-26 @ 2:49 PM
Study NCT ID:
NCT05691231
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2023-11-09
First Post:
2023-01-11
Brief Title:
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Sponsor:
NuVasive
Organization:
NuVasive
Study Overview
Official Title:
Long-Term Assessment of the Safety and Performance of the NuVasive Simplify Disc at Two Levels
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2023-11
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:
A prospective multicenter post-market clinical follow-up study to evaluate the 10-year long-term safety and effectiveness of the Simplify Disc at two levels in subjects who were enrolled in the IDE study NCT03123549 andor post approval study NCT04980378
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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?:
None