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Hydrogel cap aims to ease pain after nerve surgery

NCT ID NCT07246980

Symptom relief Sponsor: Tulavi 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Sep 21, 2026 · Updated 5 times

Summary

This study is tracking 1,000 people who have received or will receive the Allay Hydrogel Cap, a gel device placed during nerve surgery to protect the nerve ending. Researchers are collecting real-world data on pain levels, medication use, and complications to see how safe and helpful the cap is. The goal is to better understand if this cap can reduce pain and improve recovery after procedures like amputation or neuroma removal.

What this could mean

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

Active substance
Allay Hydrogel Cap (implantable hydrogel device)
What this could lead to
If successful, this could confirm that the cap safely reduces pain and complications after nerve surgery, offering a reliable option for patients.
What could go wrong
This is an observational registry, not a controlled trial, so results may be less definitive. The device is already in use, and the study mainly tracks outcomes rather than proving effectiveness.

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.

Participants

About 1,000 people

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

Started

May 2026

Expected to finish

May 2029

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.

Who is studied

All patients who received or will be receiving allay™ Hydrogel Cap at a participating study site are eligible for enrollment.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Patients who have or will receive allay™ Hydrogel Cap Exclusion Criteria: * Patients who have not received allay™ Hydrogel Cap

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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

    5 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

  • Complete Foot and Ankle Care of North Texas, PA

    RECRUITING

    Denton, Texas, 33702, United States

  • Florida Orthopedic Institute

    RECRUITING

    St. Petersburg, Florida, 33702, United States

  • Kaiser Permanente

    RECRUITING

    Redwood City, California, 94063, United States

  • Orlando Health

    RECRUITING

    Orlando, Florida, 32806, United States

  • University of Colorado Anschutz.

    RECRUITING

    Englewood, Colorado, 80112, United States

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