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Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study
Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success (COMPASS) Study: An Open Label Registry Study to Assess the Safety and Performance of the Allay™ Hydrogel Cap
Who can join
All ages · All sexes
Full eligibility criteria
Inclusion Criteria: * Patients who have or will receive allay™ Hydrogel Cap Exclusion Criteria: * Patients who have not received allay™ Hydrogel Cap
About the study
is is a multi-center, open-label, observational registry study (both prospective and retrospective) designed to evaluate the safety and performance of the allay™ Hydrogel Cap. This cap is an in situ forming implantable hydrogel medical device used in various peripheral nerve surgeries, including amputation and neuroma excision.
The study aims to gather demographic, operative, and clinical outcomes data from patients who have received the device.
The primary endpoints focus on the device's clinical performance, assessed using patient-reported outcomes (PROs). These include tracking changes in pain scores, pain intolerance, and cold intolerance, as well as the incidence of neuroma recurrence and changes in pain medication use from baseline.
Secondary endpoints concentrate on safety, monitoring the incidence of device failures, surgical complications, unplanned re-operations, and unexpected adverse device events (UADEs) within the study population. Essentially, the registry is collecting real-world data to determine how well and how safely the allay™ cap performs in a clinical setting.
What is being tested
- Nerve Cap (device)
Sponsor: Tulavi Therapeutics,Inc. · Participants: 1,000 · Started: May 6, 2026
Contact the study team
Official record on ClinicalTrials.gov — NCT07246980
Locations in the U.S.
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.