Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06335394
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-28
First Post:
2023-11-21
Brief Title:
Prospective Study in Adults Evaluating Safety Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion
Sponsor:
Novadip Biosciences
Organization:
Novadip Biosciences
Study Overview
Official Title:
A Prospective Multicentre Single-arm Study in Adults to Evaluate the Safety and Preliminary Efficacy of the Autologous 3D Osteogenic Implant NVD-003 for Bone Reconstruction for the Treatment of Recalcitrant Lower Limb Nonunion
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
The goal of this clinical trial is to evaluate the safety and preliminary efficacy of the autologous 3D osteogenic implant NVD-003 for bone reconstruction for the treatment of recalcitrant lower limb nonunion
Detailed Description:
This is a first in man study conducted as a prospective single-arm non-randomized clinical study A sample of 5 to 10 patients will be enrolled in the study in order to assess the safety of the use of NVD-003 bone graft implantation in patients with recalcitrant lower limb nonunion
The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP
The sample size of 5 to 10 patients was considered sufficient to give a preliminary indication on the safety of the ATMP
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