RecruitingPhase 1Phase 2NCT06532253

Long-term Safety Trial with NVDX3

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


Sponsor

Novadip Biosciences

Enrollment

15 participants

Start Date

Aug 22, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • 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.

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Interventions

DRUGNVDX3

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


Locations(1)

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

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NCT06532253


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