Long-term Safety Trial with NVDX3

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-22

Study Completion Date

2036-03-31

Brief Summary

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

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Detailed Description

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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

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Distal Radius Fractures Degenerative Lumbar Spondylolisthesis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NVDX3 implant

NVDX3 implant is a sterilized, dry powder. The total administered quantity of NVDX3 implant depends on the bone defect size/intervertebral disc space.

Group Type EXPERIMENTAL

NVDX3

Intervention Type DRUG

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

Interventions

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NVDX3

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No