NCT07246980

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

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: Tulavi Therapeutics,Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Peripheral Nerve Injuries

Interventions

Type	Name	Description
DEVICE	Nerve Cap	Patients who have or will receive allay Hydrogel Cap

Timeline

• Start date: 2026-01-01
• Primary completion: 2029-01-01
• Completion: 2029-05-01
• First posted: 2025-11-24
• Last updated: 2025-12-02

Regulatory

• FDA-regulated device study