Observational Study to Monitor Safety and Effectiveness of the Allay Hydrogel Cap in Peripheral Nerve Surgery

What this Trial Is About

Researchers are conducting a multi-center, open-label, observational registry study to evaluate the safety and performance of the allay Hydrogel Cap. This implantable hydrogel device is used during various peripheral nerve surgeries such as amputation and neuroma removal. The study collects real-world data on patients who have received this device, focusing on its clinical effects and safety. Participants in this registry have either already received or will receive the allay Hydrogel Cap during their peripheral nerve surgery. The study tracks these patients over time, gathering information related to demographics, surgical outcomes, and clinical progress. Both prospective and retrospective data collection methods are used to follow patient experiences with the device. Throughout the study, participants will provide patient-reported outcomes that measure changes in pain levels, pain interference, cold intolerance, and neuropathic pain quality at multiple time points up to 24 months after surgery. Researchers also assess changes in pain medication use and monitor for device failures, surgical complications, unplanned re-operations, and unexpected adverse device events for up to two years post-surgery. This comprehensive follow-up aims to understand both the devices performance and safety in everyday clinical use.

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