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

NCT ID: NCT05651646

Last Updated: 2022-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-13

Study Completion Date

2023-07-31

Brief Summary

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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.

Detailed Description

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The purpose of the Spinal Cord Stimulator (SCS) trial system is to determine if spinal cord stimulation is effective in adequately relieving the patient's pain and or improving function. Dorsal column stimulator trials are performed in a hospital outpatient setting. Under fluoroscopy, the physician inserts a trial lead into the epidural space. The lead is connected to a cable and an external generator worn over the body. Via the external generator, the physician tests various lead positions and stimulation parameters to identify optimal positions and settings. Then the patient is sent home with the temporary device in place. After the trial period of anywhere between 7 to 10 days, the physician meets with the patient to evaluate the effect of spinal cord stimulation and to determine if the permanent implantation is appropriate for the patient. After the discussion, the physician proceeds to remove the trial leads after carefully removing the adhesives tapes and gentle traction of leads.

Issues faced with trial lead anchoring: During the procedure after the trial leads are placed in the desired segment of the spinal cord, the remaining portion of the leads at the insertion site are coiled, and along with the device it is adhered to the skin by using wide soft cloth surgical tapes. Also, to absorb the blood and fluid oozing at the lead insertion site, soft surgical gauze is used as an absorbent pad. During this part of the procedure, there is a risk of lead displacement either while coiling the leftover lead or while using the wide surgical tape. Also, using only the soft, absorbent surgical gauze might increase the incidences of potential infection.

Proposed solution: Stimfix Trial lead anchoring system comes with the right and left clips which can hold the respective side of the leads above the skin. This system reduces the rate of displacement of the leads in the epidural space. The device is made of flexible polyurethane that allows for malleability during use for the one week. In addition foam that is silver impregnated and absorbable allows for potential reduced rates of infection and need for external absorbent pad.

Aim 1: A total of 50 subjects who are undergoing dorsal column stimulator trial will be studied and placed on the SECURE study where their trial leads will be anchored using the StimfixTM system. The trial duration will be for seven days as per standard of care.

Conditions

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Pain

Keywords

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Dorsal Column Stimulator Leads Dorsal Column Stimulator trial lead anchoring system STIMFIX ACCUFIX

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Stimfix Trail lead Anchor System for Dorsal Column Stimulator Trail Leads: A single-arm, Open-label, Multicenter (SECURE Study)
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional Arm

A total of 50 subjects who are undergoing dorsal column stimulator trial will be studied and placed on the SECURE study where their trial leads will be anchored using the StimfixTM system. The trial duration will be for seven days as per standard of care.

Group Type EXPERIMENTAL

Intervention Arm (STIMFIX)

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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STIMFIX

OTHER

Sponsor Role lead

Responsible Party

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Dipan Patel MD

MD, Interventional Pain Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Dipan Patel, MD

Role: PRINCIPAL_INVESTIGATOR

Garden State Pain Control Center

Saurabh Dang, MD

Role: PRINCIPAL_INVESTIGATOR

Garden State Pain Control Center

Phillip Lim, DO, MPH

Role: PRINCIPAL_INVESTIGATOR

Nuvation Pain Group

Jack Diep, MD, D.ABA

Role: PRINCIPAL_INVESTIGATOR

Lakeside Spine and Pain

Locations

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Lake side spine & pain

Lake Havasu City, Arizona, United States

Site Status RECRUITING

Nuvation Pain Group

Los Angeles, California, United States

Site Status RECRUITING

Garden State Pain Control Center

Clifton, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Lakshmi Rekha Narra

Role: CONTACT

Phone: 213-447-8579

Email: [email protected]

Krishnan Chakravarthy, MD, Ph.D

Role: CONTACT

Phone: 716-908-2392

Email: [email protected]

Facility Contacts

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Jack Diep, MD,D.ABA

Role: primary

Phillip Lim, DO, MPH

Role: primary

Dipan Patel, MD

Role: primary

References

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Green M, Narra L, Dang S, Diep J, Patel D, Lim P, Atallah J, Chakravarthy K. STIMFIX anchoring in percutaneous spinal cord stimulation trials: interim analysis of a multicenter study. Pain Manag. 2025 Aug;15(8):477-489. doi: 10.1080/17581869.2025.2527576. Epub 2025 Jul 8.

Reference Type DERIVED
PMID: 40624980 (View on PubMed)

Other Identifiers

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STIMFIX001

Identifier Type: -

Identifier Source: org_study_id