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Proof-of-concept Study With NVDX3 for Treatment of Distal Radius Fractures.

Distal Radius Fractures Clinical Trial

Official title:
A First-in-human Proof-of-concept Study With NVDX3, an Osteogenic Implant of Human Allogenic Origin, in the Treatment of Distal Radius Fractures in Adults.

Clinical Trial Summary

Prospective, single arm, monocentric clinical study to test NVDX3 in patients suffering from distal radius fracture. NVDX3 will be implanted during a single surgical intervention.

Clinical Trial Description

This is a prospective, single arm, monocentric first-in-human PoC study in adult patients, suffering from a distal radius fracture, treated during the surgical intervention with NVDX3, an osteogenic implant from human allogeneic origin. As per standard of care, patients with DRF are followed up to 3 months post-intervention. In the context of this trial, patient safety and IMP efficacy will be followed up to 12 months post-implant surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05987033
Study type Interventional
Source Novadip Biosciences
Contact
Status Active, not recruiting
Phase Phase 1/Phase 2
Start date August 9, 2023
Completion date December 20, 2025
View Details
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