Search / Trial NCT06616025

This Study Will Evaluate the Effectiveness of NTX-001, a Surgical Nerve Repair Product When Used in People With Upper Extremity Nerve Lacerations.

Launched by NEURAPTIVE THERAPEUTICS INC. · Sep 24, 2024

Trial Information

Current as of October 04, 2024

Not yet recruiting

Keywords

Transected Nerves Requiring Surgical Repair Upper Extremity

Description

NTX-001 has been developed as a surgical product to be used in conjunction with standard suture neurorrhaphy of a severed nerve. Use of NTX-001 is intended to safely accelerate the often slow and diminished return of function in repaired nerves. It often takes months and/or years to determine if function will be restored. By that point, restoration is often incomplete and can result in lifelong motor and/or sensory deficits. By reconnecting (PEG-fusion) a substantial number of axons within a severed nerve, the degeneration-regeneration cycle and subsequent atrophy may be reduced or even pre...

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • * The subject has voluntarily agreed to participate in this study and has signed an Institutional Review Board (IRB) approved informed consent form.
  • * The subject is between eighteen (18) and eighty (80) years of age.
  • * The subject has clinical evidence of a Sunderland's 4th degree (Class II) or 5th degree (Class III) nerve transection(s) that has resulted in upper extremity nerve impairment that requires surgical treatment.
  • Exclusion Criteria:
  • * Subjects whose nerve repair will occur greater than 48 hours after nerve transection.
  • * Subjects requiring nerve repair involving an autograft, allograft or conduit(s).
  • * Subjects with multiple transected nerve injuries are allowed into the study only if all injuries are amenable to direct repair.
  • * Subjects who, in the judgement of the investigator, are not likely to demonstrate meaningful recovery within a reasonable time frame during follow up due to significant muscle atrophy or other morbidity.
  • * The subject's injury is a result of a suicide attempt or self- harm.
  • * The subject has documented history or clinical signs of any condition where NTX-001 might not prove beneficial (e.g., systemic neuromuscular disease, systemic neurological deficit, or other treatments known to affect the growth and/or physiology of the neural and vascular system).
  • * The subject has a known allergy to polyethylene glycol (PEG) or human grade silicone.
  • * The subject is pregnant or breastfeeding.
  • * The subject is currently enrolled in another investigational study or has participated in an investigational study within 30 days prior to screening.

About Sponsor

The National Institute of Allergy and Infectious Diseases (NIAID, /ˈnaɪ.æd/) is one of the 27 institutes and centers that make up the National Institutes of Health (NIH), an agency of the United States Department of Health and Human Services (HHS). NIAID's mission is to conduct basic and applied research to better understand, treat, and prevent infectious, immunologic, and allergic diseases.

Contacts

JC

Jennifer Cobb

Immunology at National Institute of Allergy and Infectious Diseases (NIAID)

Locations

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0