Continuous Observational Monitoring Program for Allay123 Hydrogel Cap Safety and Success (COMPASS) Study: An Open Label Registry Study to Assess the Safety and Performance of the Allay123 Hydrogel Cap

What this Trial Is About

This research focuses on patients with peripheral nerve injuries who have received or will receive the allay123 Hydrogel Cap, an implantable medical device used in surgeries such as amputation and neuroma removal. The study is an open-label, observational registry conducted across multiple centers to evaluate how well the device works and how safe it is in real-world clinical use. The main goal is to collect data on patient outcomes and device performance over time. Participants in the study have or will receive the allay123 Hydrogel Cap as part of their nerve surgery. The study collects both retrospective and prospective data, including details about patient demographics, surgical procedures, and clinical results. The registry monitors changes in pain levels, pain intolerance, cold intolerance, neuroma recurrence, and pain medication use, tracking these outcomes at multiple time points up to two years after surgery. During the study, participants will complete patient-reported outcome measures at baseline (before surgery), and at 2 weeks, 1 month, 4 months, 12 months, and 24 months post-surgery. Researchers also observe safety by recording any device failures, surgical complications, unplanned re-operations, or unexpected adverse events during the two-year follow-up. This continuous monitoring helps to understand the device's performance and safety over time.

Continuous Observational Monitoring Program for Allay™ Hydrogel Cap Safety and Success Study