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Could a scaffold help nerves regrow? new trial launches

NCT ID NCT06529835

Disease control Sponsor: Auxilium Biotechnologies 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tests a new device called the NeuroSpan Bridge for repairing damaged nerves in the arms or legs. It is compared to two standard treatments: a nerve guide and a nerve graft from another part of the body. The trial will enroll 80 people with nerve injuries and measure how well they regain feeling and movement after 12 months.

What this could mean

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

Active substance
NeuroSpan Bridge (a scaffold device for nerve repair)
What this could lead to
If it works, this could offer a better option for repairing damaged nerves, potentially improving sensation and movement without needing a nerve graft from another body part.
What could go wrong
This is an early-stage trial with only 80 people, so results may not apply to everyone. The device could cause infection, inflammation, or chronic pain, and it may not work better than existing treatments.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

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

Started

Mar 2025

Expected to finish

Aug 2028

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: 1. Patients aged 18 to 80 with upper or lower extremity nerve injury with a gap of 0.5 to 3.0 cm. 2. Nerve diameter at injury site ≤3mm. 3. Nerve injury location is the arm from the shoulder to the wrist, including the hand or the leg from the hip to the ankle including the foot. 4. For Motor Nerve Injuries: Distance from site of injury to the nearest innervated muscle: ≤100mm 5. For Sensory and Mixed Nerve injuries: Distance from the site of injury to the nearest sensory nerve target: ≤250mm 6. Repair must take place within 3 months from injury 7. No contraindications to surgical repair (e.g., risk of concurrent infection, dog bite) Exclusion Criteria: 1. Previous history of nerve repair attempt at the treated nerve. 2. Concurrent disease that reduces nerve regeneration: diabetes, previous diagnosis of non-traumatic peripheral neuropathy, chemotherapy treatment, other causes of peripheral neuropathy. 3. Allergy to Bovine products such as Bovine Collagen Nerve Cuff. 4. Pregnancy or planning to become pregnant

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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 injuries

How to take part

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

  1. The places running it

    8 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

  • Medstar Union Memorial Hospital- The Curtis National Hand Center

    RECRUITING

    Baltimore, Maryland, 21218, United States

  • NYU Langone Orthopedic Center

    RECRUITING

    New York, New York, 10003, United States

  • OSU Wexner Medical Center

    RECRUITING

    Columbus, Ohio, 43212, United States

  • The San Antonio Orthopaedic Group (TSAOG Orthopaedics)

    RECRUITING

    San Antonio, Texas, 78258, United States

  • UC San Diego Health

    RECRUITING

    San Diego, California, 92103, United States

  • UCSF Orthopedic Institute

    RECRUITING

    San Francisco, California, 94158, United States

  • UT Health Houston

    RECRUITING

    Houston, Texas, 77030, United States

  • University of Pennsylvania- Penn Presbyterian Medical Center

    RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.