STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads (SECURE Study)

Launched by STIMFIX · Dec 7, 2022

Keywords

ClinConnect Summary

The STIMFIX study is looking into a new system called the Stimfix Trail lead anchor, which aims to help patients who are trying a treatment for pain relief known as dorsal column stimulation. This treatment involves placing small leads in the epidural space of the spine to send electrical signals that can help reduce pain. While this method has been used for many years and is performed on about 100,000 patients each year, some people experience problems during a test period where the leads can move out of place, affecting the results. The Stimfix system is designed to keep these leads securely in place during the trial, potentially improving outcomes for patients.

To participate in this study, you need to be at least 18 years old and be undergoing a spinal cord stimulator trial specifically for failed back surgery issues. You also need to be able to understand the study and give your permission to participate. If you have allergies to adhesives or materials used in the study, you won’t be eligible. Participants in this trial can expect to have their leads anchored more securely, which may help reduce the chance of trial failure. The study is currently recruiting participants of all genders, and it’s a chance to contribute to a project that could improve pain management for many people.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Must undergo Spinal Cord Stimulator trial for failed back surgical syndrome and must meet standard of care inclusion criteria for spinal cord stimulator therapy
• • 18 years of age or older
• • Must have the cognitive capacity to provide consent/permission
• • Must demonstrate understanding the benefit of StimfixTM, its purpose and subject participation
• Exclusion Criteria:
• • Known allergies to adhesives and to any material to be used in this project

Trial Officials