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Recruiting NCT07246980

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

— Observational Peripheral Nerve Injuries

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Nerve Cap.
Who it may be relevant to
Registry conditions: Peripheral Nerve Injuries. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device Nerve Cap
    Patients who have or will receive allay Hydrogel Cap

Primary outcome measures

  • Assessment of change in Pain Scores from baseline using VAS [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)]
  • Assessment of change in Pain scores from baseline using Numerical Rating Scale [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)]
  • Assessment of change in Pain Interference from baseline using PROMIS PI Short Form 5b [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)]
  • Assessment of change in Neuropathic Pain Quality from baseline using Patient-Reported Outcome Measurement Information System (PROMIS) v2.0 Neuropathic Pain Quality 5a [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)]
  • Assessment of change in Cold Intolerance from baseline using Cold Intolerance Symptom Severity (CISS) score [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 month and 24 month (Post Surgery)]
  • Assessment of change from baseline in the average quantity of pain medication taken via the Medication Quantification Scale (MQS) at 12 months. [Time frame: Baseline (Pre Surgery ), 2 Weeks, 1 month, 4 month, 12 months (Post Surgery)]
Secondary outcome measures (1)
  • Incidence of Device Failures surgical & medical complications, unplanned re-operations, and unexpected adverse device events (UADEs) [Time frame: Upto 2 years Post Surgery]

Eligibility criteria

Inclusion criteria

  • Patients who have or will receive allay™ Hydrogel Cap

Exclusion criteria

  • Patients who have not received allay™ Hydrogel Cap

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 3 centers
  • Orlando Health — Orlando
  • Florida Orthopedic Institute — St. Petersburg
  • Complete Foot and Ankle Care of North Texas, PA — Denton

Identifiers

NCT: NCT07246980 · CLP-0002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗