NCT06532253

Long-term Safety Trial with NVDX3

Long-term Safety Bucket Trial with NVDX3, an Osteogenic Implant of Human Allogenic Origin.

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 15 (estimated)
• Sponsor: Novadip Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

An study evaluating the long-term safety of all patients previously treated with NVDX3.

Detailed description

An study evaluating the long-term safety of all patients previously treated with NVDX3 (referred to as the "core NVDX3 trial"). All patients having signed the ICF enter the long term follow-up study.

Conditions

• Distal Radius Fractures
• Degenerative Lumbar Spondylolisthesis

Interventions

Type	Name	Description
DRUG	NVDX3	NVDX3 is implanted during a single surgical intervention, that took place in the core trials (refer to NCT05961956 and NCT05987033)

Timeline

• Start date: 2024-08-22
• Primary completion: 2036-03-01
• Completion: 2036-03-01
• First posted: 2024-08-01
• Last updated: 2024-09-05

Locations

1 site across 1 country: Luxembourg