Long-term Safety Trial with NVDX3

Launched by NOVADIP BIOSCIENCES · Jul 29, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the long-term safety of a treatment called NVDX3, which is used for conditions like distal radius fractures (wrist fractures) and degenerative lumbar spondylolisthesis (a problem in the lower back). The trial is currently recruiting participants who have already been treated with NVDX3 in previous studies. It aims to ensure that this treatment remains safe over a longer period.

To be eligible for this trial, participants must be between the ages of 65 and 74, have received an implant of NVDX3, and agree to attend yearly safety check-ups for the next 10 years. They also need to understand what the study involves and give their consent to participate. There are no exclusions based on other factors, so if you meet these criteria, you may be able to join. Participants can expect regular follow-ups to monitor their health and any potential effects of the treatment over time.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patient being implanted with NVDX3.
• • 2. Previously participated to one of the NVDX3 core clinical trials.
• • 3. Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
• • 4. Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
• Exclusion Criteria:
• • No exclusion criteria are applicable.