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TerminatedNCT05199155Updated Nov 14, 2024

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

A Phase 2 interventional study of NerVFIX in Nerve Injury and Nerve Lesion, sponsored by TBF Genie Tissulaire. Terminated at 2 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-14.

Sponsored by TBF Genie Tissulaire · Phase 2, Interventional, and Treatment

Why this study was terminated
Low accrual rate

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Dec 2020, registered Dec 2021).
Phase
Phase 2
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
01

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.

02

Conditions studied

  • Nerve Injury
  • Nerve Lesion
03

In context

Lead sponsor

TBF Genie Tissulaire is the lead sponsor of 20 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (actual)

Study arms

  • Experimental
    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

    Biological: NerVFIX

Interventions

  • BiologicalNerVFIX

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

06

What researchers measure

Primary outcomes

  1. Recovery of sensory function

    Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD)

    Time frame: 12 months

Secondary outcomes

  1. Progressive recovery of sensory function

    Improvement in the s2PD

    Time frame: 15 days, 1 month, 3 months, 6 months, 12 months

  2. Decrease of the score of symptoms related to nerve section

    Score of cold sensitivity, hyperaesthesia and numbing (0 = no complication, 4 = major complication) and score of pain to the pressure (0 = no pain, 10 = worst imaginable pain)

    Time frame: 15 days, 1 month, 3 months, 6 months, 12 months

  3. Improvement of the touch-pressure threshold of the hand

    Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests

    Time frame: 15 days, 1 month, 3 months, 6 months, 12 months

  4. Percentage of nerve regeneration

    Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign

    Time frame: 1 month, 3 months, 6 months, 12 months

  5. Improvement of health-related quality of life

    Quality of life related to nerve section of the hand evaluated using Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH) questionnaire (0 = no disability, 100 = most severe disability)

    Time frame: 15 days, 1 month, 3 months, 6 months, 12 months

  6. Improvement of clinical motricity

    Improvement of thumb opposition in case of median nerve section or of Froment's sign, abduction and adduction of the fingers and movement of the 4th and 5th digit in case of ulnar nerve section

    Time frame: 15 days, 1 month, 3 months, 6 months, 12 months

07

Study locations

2 sites
  • Clinique de la Main - Nantes Atlantique
    Saint-Herblain, 44800, France
  • Institut Chirurgical de la Main et du Membre Supérieur
    Villeurbanne, 69100, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05199155
Lead sponsor
TBF Genie Tissulaire
Responsible party
Sponsor
First posted
Jan 20, 2022
Start date
Dec 8, 2020
Primary completion
Aug 13, 2024
Completion
Aug 13, 2024
Last update
Nov 14, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.

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