Status:
TERMINATED
Use of a Nerve Regeneration Conduit (NerVFIX®) in the Treatment of Nerve Section of the Wrist
Lead Sponsor:
TBF Genie Tissulaire
Conditions:
Nerve Injury
Nerve Lesion
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 8 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 13 2024
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT05199155
Start Date
December 8 2020
End Date
August 13 2024
Last Update
November 14 2024
Active Locations (2)
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1
Clinique de la Main - Nantes Atlantique
Saint-Herblain, France, 44800
2
Institut Chirurgical de la Main et du Membre Supérieur
Villeurbanne, France, 69100