Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist

TBF Genie Tissulaire

Status and phase: Terminated; Phase 2

Conditions: Nerve Lesion; Nerve Injury

Treatments: Biological: NerVFIX

Study type: Interventional

Funder types: Industry

Identifiers

NCT05199155

NerVFIX-TBF2

2019-A03050-57 (Registry Identifier)

Details and patient eligibility

About

The purpose of this open, multicenter trial is to assess the impact of a nerve regeneration conduit made of allogeneic artery or vein from umbilical cord lining on the regeneration of wrist nerve.

Enrollment: 12 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Men and women over 18 years of age and under 65 years of age
• One wrist nerve section ( medial, ulnar) with a minimum of 2 mm and maximum gap of 2 cm evaluated during the surgical procedure (Sunderland Grade V)
• Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nerve junction
• Poor outcome on the Mackinnon-Dellon scale: < S3
• Within 1 month of the injury or accident event and/or at the time of the injury (emergency procedure)
• Any damaged artery must be repaired
• Patient with no poor vascularization risk (no surgical treatment of vessel section) or no disease linked to poor vascularization.
• Patient who received the study information and provided consent
• Patients who are members or the beneficiary of a national health insurance plan

Exclusion criteria

• Breast feeding women or women without effective contraception (if no effective contraception: a pregnancy test is mandatory)
• Digital nerve section
• Pregnant or breast feeding women: Women of childbearing age will be asked to undergo a pregnancy test before being enrolled into the study and to use an effective birth control method
• Patient who suffered amputation of the hand in question
• Surgical site infection or necrotic area; tendon and/or bone damage
• Underlying motor or sensory disorder that could compromise the evaluation; inflammatory arthritis causing pain
• Disease that compromises healing such as diabetes, alcoholism or skin disorder
• Vascular disease leading to reduced blood flow or altered microvascularisation such as Raynaud's disease
• Subjects who are unlikely to follow through with rehabilitation or who could be addicted to drugs or alcohol; heavy smokers will be asked to stop smoking voluntarily
• Persons confined by a judicial or administrative decision
• Adults subject to legal protection measures or who are unable to provide their consent

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

NerVFIX

Experimental group

Description:

Biological regeneration nerve conduit of allogeneic artery or vein from umbilical cord used as a conduit for gap \< 2 cm or as a wrap after peripheral nerve suture

Treatment:

Biological: NerVFIX