Recruiting

STIMFIX

Sponsor:

STIMFIX

Code:

NCT05651646

Conditions

Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Intervention Arm (STIMFIX)

Study Details

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

Study ID

NCT05651646

Start date

May 13, 2021

Status verified date

Dec, 2022

Completion date

Jul, 2023

Anticipated

Primary completion date

Jul, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • To measure the Average Lead Migration in all 50 patients during the post trail follow up period [ Time Frame: 7 days or Depending on the Post trial Period (Per standard of care) ]

Central Contacts and Locations

Central contacts

Lakshmi Rekha Narra

213-447-8579stimfixanchors@gmail.com

Krishnan Chakravarthy, MD, Ph.D

716-908-2392stimfixanchors@gmail.com

Locations

Lake side spine & pain

Recruiting

Lake Havasu City, Arizona, United States, 86403

Contacts

Jack Diep, MD,D.ABA

928-505-5555stimfixanchors@gmail.com

Nuvation Pain Group

Recruiting

Los Angeles, California, United States, 90621

Contacts

Phillip Lim, DO, MPH

714-676-5541stimfixanchors@gmail.com

Garden State Pain Control Center

Recruiting

Clifton, New Jersey, United States, 07013

Contacts

Dipan Patel, MD

973-270-9906stimfixanchors@gmail.com

More Information

Sponsor

STIMFIX

Last update posted

Dec 15, 2022

Last verified

Dec, 2022

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by STIMFIX on 2022-12-15.