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New gel promises better nerve repair after severe arm injuries

NCT ID NCT06616025

Disease control Sponsor: Neuraptive Therapeutics Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 5 times

Summary

This Phase 3 trial tests a product called NTX-001, a set of three solutions applied during surgery to help reconnect severed nerves in the arm. About 98 adults with severe nerve cuts will be randomly assigned to receive either standard nerve stitching plus NTX-001 or standard stitching alone. The main goal is to see if NTX-001 improves hand function and reduces pain 24 weeks after surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
NTX-001 (PEG-Fusion) - a set of three solutions applied to the nerve repair site during surgery
What this could lead to
If it works, this could lead to better recovery of hand function and less pain after severe nerve injuries in the arm.
What could go wrong
This is a Phase 3 trial, but it's still relatively small (98 people). The improvement over standard surgery may be modest, and results may not apply to all nerve types or injuries.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 98 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Peripheral Nerve Injuries traumatic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Peripheral nerve injury (PNI) Peripheral nerve injury upper limb

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Allegheny Health Network

    RECRUITING

    Pittsburgh, Pennsylvania, 15212, United States

  • Barnes-Jewish Hospital 1 Barnes Jewish Hospital Plaza St.

    RECRUITING

    St Louis, Missouri, 63110, United States

  • Baylor, Scott and White Health

    RECRUITING

    Dallas, Texas, 75246, United States

  • Cedars Sinai Medical Center

    NOT_YET_RECRUITING

    Los Angeles, California, 90048, United States

  • Curtis National Center at MedStar Union Memorial Hospital

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • Grady Health

    RECRUITING

    Atlanta, Georgia, 30303, United States

  • Harborview Medical Center

    RECRUITING

    Seattle, Washington, 98104, United States

  • Louisiana State University Health Sciences Center

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29429, United States

  • Missouri Orthopaedic Institute

    RECRUITING

    Columbia, Missouri, 65211, United States

  • NYU Langone Health

    RECRUITING

    New York, New York, 10003, United States

  • Orlando Health Orlando Regional Medical Center

    RECRUITING

    Orlando, Florida, 32806, United States

  • Rothman Orthopedics - Advent Health

    RECRUITING

    Orlando, Florida, 32804, United States

  • Texas Tech

    RECRUITING

    Lubbock, Texas, 79415, United States

  • The Cooper Health System

    RECRUITING

    Camden, New Jersey, 08103, United States

  • The MetroHealth System

    RECRUITING

    Cleveland, Ohio, 44109, United States

  • The Ohio State University Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43212, United States

  • UC Health

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • UVA Health

    RECRUITING

    Charlottesville, Virginia, 22903, United States

  • University of Chicago

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Cincinnati Health

    RECRUITING

    Cincinnati, Ohio, 45267, United States

  • University of Louisville

    RECRUITING

    Louisville, Kentucky, 40202, United States

  • University of Pennsylvania, Department of Orthopaedic Surgery

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • University of Utah Health

    NOT_YET_RECRUITING

    Salt Lake City, Utah, 84132, United States

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