Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT06915662
Phase
PHASE2
Status
Recruiting
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Conditions

  • Neuroma
  • Neuropathic Pain

Eligibility Criteria

Sex
ALL
Age
22 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tulavi allay Nerve Cap — DEVICE
    The Tulavi allay Nerve Capfirst and only fully absorbable in situ forming technology designed to protect transected nerves, prevent axonal escape, and reduce the risk of neuroma formation. https://tulavi.com/allay-nerve-cap/

Study Details

In 2016, one in five individuals in the United States (US) experienced chronic pain, and approximately 40% of them suffered from neuropathic pain. The physical and emotional burden on patients results in costs of billions of dollars annually. Digital amputations affect over 23,000 people each year in the US and may lead to neuropathic pain and neuroma formation in the transected nerves. Previous studies have reported a 6.6% incidence of symptomatic neuroma, and more than 60% of these patients require surgery to reduce the negative impact on their daily living activities. To minimize neuroma formation after digital amputation, various techniques have been described, such as traction neurectomies (TN) and dorsal transpositions (DT), with and without nerve coaptation. However, it remains unclear whether these techniques improve patient-reported outcome measures in individuals undergoing this type of procedure. Previously published studies are descriptive in nature, focus on a single surgical technique, or include patients with established symptomatic neuromas. The only prospective trial on this topic was published in 2000 and compared two conventional techniques that have since been modified to better minimize neuroma formation or to reduce mechanical pressure by transposing the nerve ends to the dorsal aspect of the hand. However, that study used different scales to measure outcomes and did not incorporate aspects of pain that affect patients' emotional and social well-being. Currently, two randomized controlled trials are enrolling patients. One compares surgical techniques for the treatment of neuroma rather than its prevention. The other excludes digits with injuries located distal to the interphalangeal joints. Both studies focus on more complex surgical techniques. Given the extent of this problem, there has been recent innovation aimed at preventing neuroma formation. One promising product is the Tulavi Allay™ Nerve Cap, which has demonstrated encouraging results in basic science studies and anecdotally in early clinical use cases. In this study, the investigators have designed a prospective trial to assess the efficacy of the Tulavi Allay™ Nerve Cap when used to prevent symptomatic digital nerve neuroma following traumatic digital amputation.

Key Dates

Start date
Sep 20, 2025
Status verified
Apr 2026
Primary completion
Apr 30, 2027
Completion
Apr 30, 2027

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Tulavi allay Nerve Cap
    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. All adult patients, satisfying the inclusion and exclusion criteria, are eligible for enrollment in this study regardless of sex, race, or ethnicity. Vulnerable populations will not be recruited.

Primary Outcome Measure

Visual Analog / Numerical Rating Scale (VAS/NRS) Scores) [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalBostonMassachusetts02114
Abhiram Bhashyam, MD, PhD
[email protected]
617-726-4700
Sujit Chepuri, BA
[email protected]
617-726-1569

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By research site
Massachusetts General Hospital· Boston, MA

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