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

NCT05651646 | Unknown DMC

• 1 other identifier: STIMFIX001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief 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

Pain

Keywords

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

Outcome Measures

Primary Outcomes (1)

• To measure the Average Lead Migration in all 50 patients during the post trail follow up period

  Specific Survey Data To Be Collected From Patients and Associated Time Points for achieving primary outcome: Day 0: Trial placement: Prior to StimfixTM placement on both leads - AP and Lateral Fluoroscopy Images and impedance checks for each lead Day 0: Trial placement: After each StimfixTM is placed on an individual lead check of AP and Lateral Fluoroscopy Images and impedance check Day 0: After completing the procedure, Will ask the patient to flex his body while standing and return to a prone position for imaging. Ap and lateral fluoroscopy images will be taken to check if the change in the posture is effecting the lead position Trial Day 7: Prior to removal of leads and StimfixTM device, obtain final AP and Lateral Fluoroscopy Images. Fluoroscopy measurement protocol: In all the images taken above following protocol is used to measure the change in lead migration:

  7 days or Depending on the Post trial Period (Per standard of care)

Study Arms (1)

Interventional Arm

EXPERIMENTAL

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.

Other: Intervention Arm (STIMFIX)

Interventions

Intervention Arm (STIMFIX) 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.

Interventional Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

Sponsors & Collaborators

• STIMFIX: lead

Study Sites (3)

Lake side spine & pain

Lake Havasu City, Arizona, 86403, United States

RECRUITING

Nuvation Pain Group

Los Angeles, California, 90621, United States

RECRUITING

Garden State Pain Control Center

Clifton, New Jersey, 07013, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 40624980 DERIVED

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dipan Patel, MD

  Garden State Pain Control Center

  PRINCIPAL INVESTIGATOR

• Saurabh Dang, MD

  Garden State Pain Control Center

  PRINCIPAL INVESTIGATOR

• Phillip Lim, DO, MPH

  Nuvation Pain Group

  PRINCIPAL INVESTIGATOR

• Jack Diep, MD, D.ABA

  Lakeside Spine and Pain

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lakshmi Rekha Narra

CONTACT

213-447-8579; stimfixanchors@gmail.com

Krishnan Chakravarthy, MD, Ph.D

CONTACT

716-908-2392; stimfixanchors@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Interventional Pain Physician

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

Study Record Dates

• First Submitted: December 7, 2022
• First Posted: December 15, 2022
• Study Start: May 13, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: December 15, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (3)