Status:
RECRUITING
Long-term Safety Trial with NVDX3
Lead Sponsor:
Novadip Biosciences
Collaborating Sponsors:
PrimeVigilance
Data Investigation Company Europe (DICE)
Conditions:
Distal Radius Fractures
Degenerative Lumbar Spondylolisthesis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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.
Eligibility Criteria
Inclusion
- Patient being implanted with NVDX3.
- Previously participated to one of the NVDX3 core clinical trials.
- Patient accepts to comply to a yearly follow-up safety visit for 10 additional years
- Patient has understood and accepted to participate in the long-term follow-up study by signing the informed consent.
Exclusion
- No exclusion criteria are applicable.
Key Trial Info
Start Date :
August 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2036
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT06532253
Start Date
August 22 2024
End Date
March 1 2036
Last Update
September 5 2024
Active Locations (1)
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1
Centre Hospitalier de Luxembourg
Luxembourg, Luxembourg, 1210