Tulavi Allay Nerve Cap for Neuroma
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.12345
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.12467
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Surgery and Initial Treatment
Participants undergo digital amputation surgery with the application of the Tulavi Allay™ Nerve Cap
Post-operative Monitoring
Participants are monitored post-operatively with questionnaires administered at multiple time points to assess pain and neuroma prevention
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tulavi allay Nerve Cap
Find a Clinic Near You
Who Is Running the Clinical Trial?
Massachusetts General Hospital
Lead Sponsor
Tulavi Therapeutics, Inc
Collaborator
Tulavi Therapeutics,Inc.
Industry Sponsor