Long-term Safety Trial With NVDX3

Phase 1

Not yet recruiting

• Conditions: Distal Radius Fractures; Degenerative Lumbar Spondylolisthesis
• Interventions: Drug: NVDX3

• Registration Number: NCT06532253
• Lead Sponsor: Novadip Biosciences

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-29
• Study First Submitted QC: 2024-07-29
• Last Update Submitted: 2024-07-29
• Study Start: 2024-08-01
• Study First Posted: 2024-08-01
• Last Update Posted: 2024-08-01
• Primary Completion: 2036-03
• Study Completion: 2036-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 15

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.

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Exclusion Criteria

No exclusion criteria are applicable.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Long-term safety of the NVDX3 implant	Between screening (V0) and 120 months post-core study (V10)	Description of all SAEs, NVDX3 related AEs and AE of special interest

Trial Locations

Locations (1)

Centre Hospitalier de Luxembourg; 🇱🇺 Luxembourg, Luxembourg