NCT05199155

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Dec 2020

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 8, 2020

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

December 30, 2021

Completed
21 days until next milestone

First Posted

Study publicly available on registry

January 20, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 13, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2024

Completed
Last Updated

November 14, 2024

Status Verified

November 1, 2024

Enrollment Period

3.7 years

First QC Date

December 30, 2021

Last Update Submit

November 12, 2024

Conditions

Nerve InjuryNerve Lesion

Outcome Measures

Primary Outcomes (1)

  • Recovery of sensory function

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

    12 months

Secondary Outcomes (6)

  • Progressive recovery of sensory function

    15 days, 1 month, 3 months, 6 months, 12 months

  • Decrease of the score of symptoms related to nerve section

    15 days, 1 month, 3 months, 6 months, 12 months

  • Improvement of the touch-pressure threshold of the hand

    15 days, 1 month, 3 months, 6 months, 12 months

  • Percentage of nerve regeneration

    1 month, 3 months, 6 months, 12 months

  • Improvement of health-related quality of life

    15 days, 1 month, 3 months, 6 months, 12 months

  • +1 more secondary outcomes

Study Arms (1)

NerVFIX

EXPERIMENTAL

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

NerVFIXBIOLOGICAL

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

NerVFIX

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinique de la Main - Nantes Atlantique

Saint-Herblain, 44800, France

Location

Institut Chirurgical de la Main et du Membre Supérieur

Villeurbanne, 69100, France

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2021

First Posted

January 20, 2022

Study Start

December 8, 2020

Primary Completion

August 13, 2024

Study Completion

August 13, 2024

Last Updated

November 14, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)