RECRUITING

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

Conditions

Peripheral Nerve Injury Upper Limb Peripheral Nerve Injury (PNI)Transected Nerves Requiring Surgical Repair Upper Extremity

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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.

Quick Facts

Study Start:2025-02-10

Study Completion:2027-04-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06616025

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.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.

Inclusion Criteria

Exclusion 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.

Contacts and Locations

Study Contact

Seth Schulman, MD

CONTACT

215-206-9504

seth.schulman@neuraptive.com

Kristen Olszyk, MS

CONTACT

484-753-1205

kristen.olszyk@neuraptive.com

Principal Investigator

Seth Schulman, MD

STUDY_DIRECTOR

Neuraptive Therapeutics Inc.

Study Locations (Sites)

Curtis National Center at MedStar Union Memorial Hospital

Baltimore, Maryland, 21218

United States

Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

St. Louis, Missouri, 63110

United States

Collaborators and Investigators

Sponsor: Neuraptive Therapeutics Inc.

Seth Schulman, MD, STUDY_DIRECTOR, Neuraptive Therapeutics Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-10

Study Completion Date2027-04-30

Study Record Updates

Study Start Date2025-02-10

Study Completion Date2027-04-30

Terms related to this study

Keywords Provided by Researchers

Transected Nerves
Requiring Surgical Repair
Upper Extremity

Additional Relevant MeSH Terms

Peripheral Nerve Injury Upper Limb
Peripheral Nerve Injury (PNI)