Ignite Creation Date:
2024-05-06 @ 7:18 PM
Last Modification Date:
2024-10-26 @ 3:04 PM
Study NCT ID:
NCT05961956
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-12
First Post:
2023-07-11
Brief Title:
Study With NVDX3 for Treatment of Low Grade Degenerative Lumbar Spondylolisthesis
Sponsor:
Novadip Biosciences
Organization:
Novadip Biosciences
Study Overview
Official Title:
A Proof-of-concept Study With NVDX3 an Osteogenic Implant of Human Allogenic Origin in the Treatment of Low Grade Degenerative Lumbar Spondylolisthesis by Interbody Spine Fusion in Adults
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
Prospective single arm single-center clinical study to test NVDX3 in patients suffering from low grade one level degenerative lumbar L1 - S1 spondylolisthesis NVDX3 will be implanted during a single surgical intervention
Detailed Description:
This is a prospective single arm single-center PoC study in adult patients suffering from a degenerative lumbar L1-S1 spondylolisthesis treated by spondylodesis in which NVDX3 an osteogenic implant from human allogeneic origin is used The screening and implant surgery visits will be used as the reference timepoint respectively for the clinical and the radiological efficacy outcome evaluations
As per standard of care patients with DLS are followed up to 12 months post-intervention In the context of this trial patient safety and IMP efficacy will be followed up to 24 months post-implant surgery
As per standard of care patients with DLS are followed up to 12 months post-intervention In the context of this trial patient safety and IMP efficacy will be followed up to 24 months post-implant surgery
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2022-002771-11 | EUDRACT_NUMBER | None | None |