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

Last updated: November 12, 2024
Sponsor: TBF Genie Tissulaire
Overall Status: Terminated

Phase

2

Condition

Nerve Injury

Treatment

NerVFIX

Clinical Study ID

NCT05199155
NerVFIX-TBF2
2019-A03050-57
  • Ages 18-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 2cm evaluated during the surgical procedure (Sunderland Grade V)

  • Inclusion of direct suture with wrapping or nerve defect with NerVFIX for nervejunction

  • 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

Exclusion Criteria:

  • Breast feeding women or women without effective contraception (if no effectivecontraception: a pregnancy test is mandatory)

  • Digital nerve section

  • Pregnant or breast feeding women: Women of childbearing age will be asked to undergoa pregnancy test before being enrolled into the study and to use an effective birthcontrol 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 suchas Raynaud's disease

  • Subjects who are unlikely to follow through with rehabilitation or who could beaddicted to drugs or alcohol; heavy smokers will be asked to stop smokingvoluntarily

  • Persons confined by a judicial or administrative decision

  • Adults subject to legal protection measures or who are unable to provide theirconsent

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: NerVFIX
Phase: 2
Study Start date:
December 08, 2020
Estimated Completion Date:
August 13, 2024

Connect with a study center

  • Clinique de la Main - Nantes Atlantique

    Saint-Herblain, 44800
    France

    Site Not Available

  • Institut Chirurgical de la Main et du Membre Supérieur

    Villeurbanne, 69100
    France

    Site Not Available

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