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Recruiting NCT06532253

Long-term Safety Trial with NVDX3

Phase I / Phase II Interventional Distal Radius Fractures Degenerative Lumbar Spondylolisthesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NVDX3.
Who it may be relevant to
Registry conditions: Distal Radius Fractures, Degenerative Lumbar Spondylolisthesis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Luxembourg
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Long-term safety of the NVDX3 implant [Time frame: Between screening (V0) and 120 months post-core study (V10)]

Eligibility criteria

Inclusion criteria

  • 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 criteria

No exclusion criteria are applicable.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Luxembourg · 1 center
  • Centre Hospitalier de Luxembourg — Luxembourg

Identifiers

NCT: NCT06532253 · NVDX3-CLN0X

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗