Prospective Study in Adults Evaluating Safety & Efficacy of NVD003 for Bone Reconstruction to Treat Lower Limb Nonunion
NCT06335394 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 11
Last updated 2024-03-28
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.
Conditions
- Recalcitrant Lower Limb Nonunion
Interventions
- OTHER
-
NVD003
Autologous osteogenic implant NVD-003 for bone reconstruction
Sponsors & Collaborators
-
Novadip Biosciences
lead INDUSTRY
Principal Investigators
-
Christophe Marchal, MD · CHU Ambroise Paré
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2018-08-02
- Primary Completion
- 2022-04-27
- Completion
- 2028-05-15
Countries
- Belgium
- Luxembourg
- Switzerland
Study Locations
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