Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-26 @ 4:02 AM
Study NCT ID:
NCT05277818
Status:
RECRUITING
Last Update Posted:
2022-10-31
First Post:
2022-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Post-marketing Clinical Follow-up of the Medical Device DIVA®
Sponsor:
SC Medica
Organization:
Study Overview
Official Title:
Clinical Follow-up of the DIVA® Device in Lumbar Disc Herniation Surgery
Status:
RECRUITING
Status Verified Date:
2022-10
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:
Observational, ambispective, longitudinal, comparative, open, multicentric study.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
The main objective is to compare the performance of care in patients operated with and without DIVA®.
Detailed Description:
The primary endpoint is the reoperation for any cause (excluding trauma) on the lumbar spine.
Study Oversight
Has Oversight DMC:
False
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?: