NCT05987033

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

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.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Novadip Biosciences · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Distal Radius Fractures

Interventions

Type	Name	Description
DRUG	NVDX3	NVDX3 is implanted during a single surgical intervention.

Timeline

• Start date: 2023-08-08
• Primary completion: 2024-12-19
• Completion: 2024-12-19
• First posted: 2023-08-14
• Last updated: 2026-01-28
• Results posted: 2026-01-28

Locations

1 site across 1 country: Luxembourg