Tulavi Allay nerve cap to prevent neuroma pain after finger or toe amputation
Official title: Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap: A Prospective Trial for Safety and Efficacy
Run by Massachusetts General Hospital · NCT06915662 · Data updated 2026-11-12
Tests whether placing a Tulavi Allay nerve cap on a cut digital nerve at the time of traumatic amputation reduces neuroma-related pain in adults.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 22 Years and up |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Massachusetts General Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Status | Recruiting |
| Started | September 20, 2025 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | April 17, 2026 |
| Trial ID | NCT06915662 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 22 or older who are English-speaking and undergoing a primary traumatic single or multiple digital amputation at Massachusetts General Hospital, without allergy to the device materials, are ideal candidates.
✕Probably not a fit
People having revision or non-traumatic amputations, those under 22, pregnant or breastfeeding individuals, or patients with known PEG or specified dye allergies are excluded and would not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center Phase 2 interventional trial at Massachusetts General Hospital applies the Tulavi Allay nerve cap to transected digital nerves at the time of traumatic finger or toe amputation. Participants are English-speaking adults undergoing primary traumatic digital amputation who meet device safety criteria and are followed for patient-reported pain, neuroma incidence, and emotional and social impact measures. The protocol excludes revision or non-traumatic amputations, those under 22 years, pregnant or breastfeeding individuals, and people with known allergies to device components. Study outcomes compare post-amputation pain and functional impact with historical rates and previously reported surgical techniques to determine if the nerve cap reduces symptomatic neuroma and need for later surgery.
Why it matters
Potential benefit: If successful, the nerve cap could lower the chance of painful neuroma formation after digital amputation and reduce the need for follow-up surgeries, improving daily function and comfort.
How similar studies have gone: Earlier descriptive reports and one small prospective trial comparing conventional surgical techniques exist, but the use of a synthetic nerve cap like Tulavi Allay is relatively novel with limited clinical outcome data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients undergoing traumatic amputation of a single or multiple digits 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 * Patients with a known allergy to poly (ethylene glycol) (PEG) or the color additives FD\&C Yellow No. 5 Dye (tartrazine) or FD\&C Blue No. l Dye (brilliant blue FCF).
Where it's running
-
Massachusetts General Hospital
Boston, Massachusetts, United States Recruiting
Study contacts
- Study coordinator: Abhiram Bhashyam, MD, PhD
- Email: abhashyam@mgb.org
- Phone: (617) 726 - 4700
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.