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

Description

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

Conditions

Peripheral Nerve Injury Upper Limb, Peripheral Nerve Injury (PNI)

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Study Overview

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Study Details

Study overview

NTX-001 is a single use surgical product intended for use in conjunction with standard suture neurorrhaphy of severed nerves in patients between 18 and 80.

Phase 3, Multicenter, Randomized, Subject and Evaluator Blinded, Controlled Study Evaluating the Safety and Efficacy of NTX-001 Compared to Standard of Care (Neurorrhaphy) in the Treatment of Upper Extremity Transected Nerves Requiring Surgical Repair.

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

Condition
Peripheral Nerve Injury Upper Limb
Intervention / Treatment

-

Contacts and Locations

Baltimore

Curtis National Center at MedStar Union Memorial Hospital, Baltimore, Maryland, United States, 21218

St. Louis

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St., St. Louis, Missouri, United States, 63110

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 80 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Neuraptive Therapeutics Inc.,

Seth Schulman, MD, STUDY_DIRECTOR, Neuraptive Therapeutics Inc.

Study Record Dates

2027-04-30