Allay Hydrogel Cap: Safety and Performance in Peripheral Nerve Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicenter, open-label observational registry (prospective and retrospective) to collect safety and performance data on the Allay Hydrogel Cap used in peripheral nerve procedures such as amputation and neuroma excision. The study tracks demographic and operative information along with patient-reported outcomes like pain, pain tolerance, cold intolerance, neuroma recurrence, and changes in pain medication from baseline. Secondary endpoints monitor device failures, surgical complications, unplanned re-operations, and unexpected adverse device events. Data are gathered from participating sites to understand real-world use and outcomes of the device.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients who have or will receive allay™ Hydrogel Cap

Exclusion Criteria:

* Patients who have not received allay™ Hydrogel Cap

Where it's running

• Kaiser Permanente
  Redwood City, California, United States Recruiting
• University of Colorado Anschutz.
  Englewood, Colorado, United States Recruiting
• Orlando Health
  Orlando, Florida, United States Recruiting
• Florida Orthopedic Institute
  St. Petersburg, Florida, United States Recruiting
• Complete Foot and Ankle Care of North Texas, PA
  Denton, Texas, United States Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.