Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05199155
Other study ID # NerVFIX-TBF2
Secondary ID 2019-A03050-57
Status Recruiting
Phase Phase 2
First received
Last updated
Start date December 8, 2020
Est. completion date December 2023

Study information

Verified date April 2023
Source TBF Genie Tissulaire
Contact Laurence BARNOUIN, MD
Phone 0472686909
Email laurence.barnouin@tbf-lab.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date December 2023
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
France Clinique de la Main - Nantes Atlantique Saint-Herblain
France Institut Chirurgical de la Main et du Membre Supérieur Villeurbanne

Sponsors (1)

Lead Sponsor Collaborator
TBF Genie Tissulaire

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Recovery of sensory function Recovery of sensitivity in the nerve section area evaluated using the static 2-Point Discrimination (s2PD) 12 months
Secondary Progressive recovery of sensory function Improvement in the s2PD 15 days, 1 month, 3 months, 6 months, 12 months
Secondary 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) 15 days, 1 month, 3 months, 6 months, 12 months
Secondary Improvement of the touch-pressure threshold of the hand Touch-pressure of the hand in grammes determined using Semmes-Weinstein Monofilament (SWM) tests 15 days, 1 month, 3 months, 6 months, 12 months
Secondary Percentage of nerve regeneration Nerve regeneration after surgical repair evaluated by Hoffman-Tinel sign 1 month, 3 months, 6 months, 12 months
Secondary 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) 15 days, 1 month, 3 months, 6 months, 12 months
Secondary 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 15 days, 1 month, 3 months, 6 months, 12 months
See also
  Status Clinical Trial Phase
Enrolling by invitation NCT01437332 - Molecular Mediators of Nerve Injury Signaling N/A
Completed NCT03624426 - Detection and Prevention of Nerve Injury in Shoulder Arthroplasty Surgery N/A
Recruiting NCT04662320 - Promoting Healing Of Nerves Through Electrical Stimulation N/A
Recruiting NCT04144972 - Closed-Loop Deep Brain Stimulation for Refractory Chronic Pain N/A
Completed NCT02960516 - MRI Diffusion Tensor Tractography to Monitor Peripheral Nerve Recovery After Severe Crush or Cut/Repair Nerve Injury
Completed NCT05589324 - Effects of 3D Printing Writing Assisitive Device on Feasibility in Patients With Nerve Injury
Recruiting NCT03970161 - Evaluation of Early Retinal Nerve Injury in Type 2 Diabetes Patients Without Diabetic Retinopathy N/A
Completed NCT01533337 - Free Dorsal Digital Flap for Reconstruction of Volar Soft Tissue Defect of Digits N/A
Completed NCT01528397 - Reconstruction of Proper Digital Nerve Defects in the Thumb Using a Pedicled Nerve Graft N/A
Enrolling by invitation NCT05080608 - Nerve Injury in the Hand, an Interview Study
Completed NCT03881462 - Deltoid Muscle Contribution to Shoulder Function N/A
Completed NCT05302141 - Effects of Assistive Device on ADL Function in Patients With Nerve Injury N/A
Terminated NCT01751503 - Extramembranous and Interosseous Technique of Tibialis Posterior Tendon Transfer N/A
Recruiting NCT05365282 - Association Between Radial Artery Intervention and Development of Neuropathy in the Hand - A Prospective Study
Active, not recruiting NCT03701581 - 4-aminopyridine Treatment for Nerve Injury Phase 2/Phase 3
Withdrawn NCT04270019 - Polyethylene Glycol to Improve Sensation Following Digital Nerve Laceration Phase 1/Phase 2
Completed NCT04420689 - A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery Phase 1/Phase 2
Recruiting NCT05884125 - Promoting Healing of Injured Nerves With Electrical Stimulation Therapy N/A
Recruiting NCT05611983 - Experience and Feasibility of Methods for Early Sensory Training N/A
Completed NCT02032030 - Systematic Assessment and Targeted Improvement of Services Following Yearlong Surgical Outcomes Surveys