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

Status unconfirmed · Not applicable

Conditions studied: Pain

In brief

This project will investigate the efficacy of a Stimfix Trail lead anchor system (StimfixTM) in patients undergoing dorsal column stimulator trial. In dorsal column stimulator trails, two leads are placed in the epidural space and various frequencies, pulse widths, and amplitudes are run to reduce pain perception. This therapy has been in use for the last 70 years and today there are about 100,000 implants done annually for various pain indications. The process of obtaining the therapy requires a trial period of seven days with percutaneous epidural leads connected to an external pulse generator (EPG). During this trial phase there has been incidence of lead migration in about 5-10% of patients resulting in trial failure. The function of StimfixTM is to standardize the lead anchoring procedure and to reduce the incidences of lead migration during the spinal cord stimulation trial phase.

Key facts

Study ID

NCT05651646

Run by

STIMFIX

People needed

50

Starts

2021-05-13

Expected to finish

2023-07-01

Last updated by the study team

2022-12-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Known allergies to adhesives and to any material to be used in this project

Where it is running

• Lake side spine & pain — Lake Havasu City, Arizona, United States (enrolling)
• Nuvation Pain Group — Los Angeles, California, United States (enrolling)
• Garden State Pain Control Center — Clifton, New Jersey, United States (enrolling)

Full record on ClinicalTrials.gov

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