Long-term Safety Trial with NVDX3 (X3LTFU)

Novadip Biosciences

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Degenerative Lumbar Spondylolisthesis; Distal Radius Fractures

Treatments: Drug: NVDX3

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06532253

NVDX3-CLN0X

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

No exclusion criteria are applicable.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

NVDX3 implant

Experimental group

Treatment:

Drug: NVDX3