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NCT06915662 · ClinicalTrials.gov registry record · Phase 2
Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap
A Phase 2 study, sponsored by Massachusetts General Hospital.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
NCT06915662: Recruiting Phase 2 study, sponsored by Massachusetts General Hospital.
NCT06915662 is a Phase 2 study that is actively recruiting participants, run by Massachusetts General Hospital. The registered enrollment target is 20 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06915662, a Phase 2 study, is actively recruiting participants, sponsored by Massachusetts General Hospital.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
Study Summary
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 res
Interventions
- DEVICE Tulavi allay Nerve Cap
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-09-20 |
| Est. Completion | 2027-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06915662
The ClinicalTrials.gov registry entry for NCT06915662 describes a study currently listed as recruiting, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Massachusetts General Hospital, which has 2,032 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Tulavi allay Nerve Cap is the first listed.
NCT06915662 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06915662 about?
NCT06915662 is a clinical study titled "Pain Outcomes After Digital Amputation Using Tulavi Allay™ Nerve Cap". 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 i...
What is the current status of trial NCT06915662?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2025-09-20. Estimated completion is 2027-04.
What interventions are being tested in trial NCT06915662?
The interventions under investigation include: Tulavi allay Nerve Cap (DEVICE).
Who is sponsoring clinical trial NCT06915662?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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