Tulavi Allay Nerve Cap for Neuroma

Overseen By John Fitzhenry, BA

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Massachusetts General Hospital

Disqualifiers: Revision amputation, Non-traumatic amputation, Under 22, Pregnant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called the Tulavi Allay Nerve Cap, designed to prevent painful nerve growths (neuromas) after finger amputations. Neuromas can cause severe pain and disrupt daily life, making effective prevention crucial. Early studies have shown promising results for the nerve cap, and this trial will evaluate its effectiveness in real-world use. This trial may suit individuals who have experienced a traumatic single finger amputation and speak English. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Tulavi Allay Nerve Cap is safe for preventing neuroma?

Research shows that the Tulavi Allay™ Nerve Cap is generally safe for use. The FDA has granted it special approval, indicating it is considered safe and effective based on current studies. Early tests reported no painful nerve growths, suggesting it might help prevent these after an amputation. Although these studies have not included many patients yet, the early results are promising for those considering participation in a clinical trial with this device. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

The Tulavi Allay Nerve Cap is unique because it offers a novel approach to preventing symptomatic neuromas after digit amputation by acting as a physical barrier to nerve end growth. Traditional treatments for neuromas often focus on managing pain through medication or surgical removal, but the Nerve Cap aims to prevent neuroma formation from the start. Researchers are excited because it has the potential to reduce the need for additional surgeries and long-term pain management, offering a proactive and potentially more effective solution for patients.

What evidence suggests that the Tulavi Allay Nerve Cap is effective for preventing neuroma?

Research has shown that the Tulavi Allay™ Nerve Cap, which participants in this trial will receive, may help prevent painful nerve growths, known as neuromas, after finger amputations. In animal studies, no neuromas formed within three months of using the cap. The cap protects the cut nerve and aids in better healing, potentially reducing the risk of these painful growths. Early clinical experiences have been positive, suggesting the cap could lower nerve pain by preventing these growths from forming. ^{1 2 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals who have undergone digital amputation and are at risk of developing nerve pain or neuromas. It's not clear what the exclusion criteria are, as they were not provided.

Inclusion Criteria

English-speaking

I am having one of my fingers or toes amputated due to injury at MGB.

Exclusion Criteria

Patients who are pregnant and/or breastfeeding

I am willing and able to participate in a trial study.

I am younger than 22 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery and Initial Treatment

Participants undergo digital amputation surgery with the application of the Tulavi Allay™ Nerve Cap

1 day

1 visit (in-person)

Post-operative Monitoring

Participants are monitored post-operatively with questionnaires administered at multiple time points to assess pain and neuroma prevention

12 months

5 visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tulavi allay Nerve Cap

Trial Overview

The study tests the Tulavi allay™ Nerve Cap's effectiveness in preventing neuropathic pain and neuroma formation after finger amputations. This prospective trial aims to improve patient outcomes by using this innovative device.

How Is the Trial Designed?

Group I: Tulavi allay Nerve Cap Experimental Treatment 1 Intervention

Arm 1 will include patients who satisfy the inclusion criteria and consent to the study enrollment and procedure. Surgeons will perform the procedure per their standard practice, but will use the allay™ Nerve Cap per the manufacturer's instructions to prevent potential symptomatic neuroma. Inclusion Criteria: * Patients undergoing traumatic amputation of a single digit at MGB * English-speaking Exclusion Criteria: * Patients undergoing revision amputation or non-traumatic amputation * Patients under 22 years old * Patients who are pregnant and/or breastfeeding * Unable or unwilling to participate in a trial study All adult patients, satisfying the above inclusion and exclusion criteria, are eligible for enrollment in this study regardless of sex, race, or ethnicity. Vulnerable populations will not be recruited.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Tulavi Therapeutics, Inc

Collaborator

Tulavi Therapeutics,Inc.

Industry Sponsor

Published Research Related to This Trial

In a study involving 10 rabbits, silicone capping of amputated nerves effectively prevented neuroma formation when the cap's length-to-diameter ratio was maintained between 5:1 and 10:1, indicating a specific design is crucial for success.

In a clinical trial with 18 patients suffering from traumatic neuromas, 15 patients experienced relief from pain after silicone capping, although some required revision surgery, highlighting the treatment's potential effectiveness but also the need for careful monitoring and follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The prevention and treatment of amputation neuromata by silicone capping. Swanson, AB., Boeve, NR., Lumsden, RM.[2022]

Citations

1.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/reviews/DEN230061.pdf

DEN230061, allay Nerve Cap, Tulavi Therapeutics

The benefits of the device are demonstrated in the animal study that showed there were no animals with nemoma formation (0%) within 3 months of ...

2.

ctv.veeva.com

ctv.veeva.com/study/pain-outcomes-after-digital-amputation-using-tulavi-allay-nerve-cap-a-prospective-trial-for-safety

Pain Outcomes After Digital Amputation Using Tulavi Allay ...

In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent ...

3.

tulavi.com

tulavi.com/solutions/

Solutions

The fully-absorbable allay™ Hydrogel Cap is designed to protect the transected nerve, optimizing recovery and reducing the risk of neuroma ...

4.

withpower.com

withpower.com/trial/phase-2-neuropathic-pain-3-2025-f5363

Tulavi Allay Nerve Cap for Neuroma · Info for Participants

Trial Overview The study tests the Tulavi allay™ Nerve Cap's effectiveness in preventing neuropathic pain and neuroma formation after finger amputations.

5.

mentalhealth.networkofcare.org

mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT06915662?keyword=%22CAP%22

Pain Outcomes After Digital Amputation Using Tulavi ...

One promising intervention is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in preclinical research and early clinical experience.

6.

accessdata.fda.gov

accessdata.fda.gov/cdrh_docs/pdf25/K252051.pdf

September 29, 2025 Tulavi Therapeutics, Inc. Janice Hogan ...

Performance data demonstrates that the allay™ Nerve Cap is as safe and effective as the predicate. Thus, the allay™ Nerve Cap is substantially.

7.

fiercebiotech.com

fiercebiotech.com/medtech/fda-clears-surgical-hydrogel-nerve-cap-preventing-phantom-limb-pain-amputees

FDA clears surgical hydrogel nerve cap for preventing ...

Tulavi said the nerve cap system resulted in zero neuroma growths and was shown to be safe across six preclinical studies; the approach has not ...