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Could a One-Time surgical product help regrow severed nerves?

NCT ID NCT05565846

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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Last updated Jul 09, 2026 · Updated 3 times

Summary

This trial tests a product called NTX-001, which is applied during surgery to repair completely severed nerves in the arm or face. The product combines three solutions and a device, and is given only once. The study includes people with fresh nerve injuries (within 48 hours) that need surgical repair. The goal is to see if NTX-001 can help restore nerve function better than surgery alone.

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 (a combination of three solutions and a device applied during surgery)
What this could lead to
If successful, this could offer a new way to repair severed nerves, potentially improving recovery of movement and sensation after injury.
What could go wrong
This is an early-stage, open-label study with a small number of participants. The treatment is only for fresh injuries (within 48 hours) and may not work for all nerve types or locations.

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.

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

12 to 80 years

Sex

Anyone

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: 1\. The patient has clinical evidence of a peripheral nerve transection from conditions or interventions that has or may result in motor and/or sensory impairment and requires surgical treatment. Exclusion: 1. Patients whose nerve repair will occur greater than 48 hours after nerve transection. 2. Patients requiring repair of the intracranial portion of any nerve. 3. Patients requiring a nerve repair involving an allograft or conduit. 4. Patients expected to show signs of spontaneous recovery by 12 months (e.g., Bell's palsy). 5. Patients 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. 6. The patient 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). 7. The patient has a known allergy to polyethylene glycol (PEG) or human grade silicone.

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Conditions

The condition(s) this trial relates to.

traumatic neuropathy

As listed by the trial registrant

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

Peripheral nerve transections, acute or planned in upper extremity and facial nerves

How to take part

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

  1. The places running it

    2 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

  • Harborview Medical Center

    AVAILABLE

    Seattle, Washington, 98104, United States

  • Orlando Health Orthopedic Institute

    AVAILABLE

    Orlando, Florida, 32806, United States