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

NCT05651646 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2022-12-15

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

Intervention Arm (STIMFIX)

This is a single-arm prospective multicenter clinical study recruiting 50 subjects who are already undergoing a spinal cord stimulator trial for chronic back pain secondary to failed back surgical syndrome. Each patient who is recruited for spinal cord stimulator trial for their low back pain is informed about the traditional method of managing the leads and the trail lead anchoring system. If the patient agrees for the Stimfix trail lead anchoring clips StimfixTM, then informed consent is taken for anchoring clips usage during the spinal cord stimulator trail.

Sponsors & Collaborators

  • STIMFIX

    lead OTHER

Principal Investigators

  • Dipan Patel, MD · Garden State Pain Control Center

  • Saurabh Dang, MD · Garden State Pain Control Center

  • Phillip Lim, DO, MPH · Nuvation Pain Group

  • Jack Diep, MD, D.ABA · Lakeside Spine and Pain

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-13
Primary Completion
2023-07-31
Completion
2023-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05651646 on ClinicalTrials.gov