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

NCT ID: NCT05199155

Last Updated: 2024-11-14

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-08
• Study Completion Date: 2024-08-13

Brief Summary

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.

Conditions

Nerve Injury; Nerve Lesion

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NerVFIX

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

Group Type: EXPERIMENTAL

NerVFIX

Intervention Type: BIOLOGICAL

Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit

Interventions

NerVFIX

Decellularized, freeze-dried and sterile allogeneic graft of artery or vein from umbilical cord use by the investigator as a nerve regeneration conduit

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

TBF Genie Tissulaire

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Clinique de la Main - Nantes Atlantique

Saint-Herblain, , France

Institut Chirurgical de la Main et du Membre Supérieur

Villeurbanne, , France

Countries

France

Other Identifiers

2019-A03050-57

Identifier Type: REGISTRY

Identifier Source: secondary_id

NerVFIX-TBF2

Identifier Type: -

Identifier Source: org_study_id