Long-term Safety Trial with NVDX3

Phase 2RecruitingNCT06532253

Novadip Biosciences15 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Distal Radius Fractures Degenerative Lumbar Spondylolisthesis

Interventions

NVDX3DRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centre Hospitalier de Luxembourg

Luxembourg, Luxembourg

RECRUITING

Outcomes

Primary Outcomes

Long-term safety of the NVDX3 implant

Description of all SAEs, NVDX3 related AEs and AE of special interest

Time frame: Between screening (V0) and 120 months post-core study (V10)

Central Contacts

Denis Dufrane, MD

CONTACT

+3210779220 clinical@novadip.com

Danielle Gérard, MSc

CONTACT

+32473540008 danielle.gerard@novadip.com

Data from ClinicalTrials.gov

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