Clinical trial NCT05651646: STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads (SECURE Study)
Official title: STIMFIX Trail Lead Anchor System for Dorsal Column Stimulator Trail Leads (SECURE Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pain
Keywords: Dorsal Column Stimulator Leads
Dorsal Column Stimulator trial lead anchoring system
STIMFIX
ACCUFIX
Lead sponsor: STIMFIX
Sponsor class: OTHER
First posted: 2022-12-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Stimfix Trail lead Anchor System for Dorsal Column Stimulator Trail Leads: A single-arm, Open-label, Multicenter (SECURE Study)
Primary purpose: OTHER

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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: To measure the Average Lead Migration in all 50 patients during the post trail follow up period
timeFrame: 7 days or Depending on the Post trial Period (Per standard of care)
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Havasu City
country: United States
facility: Lake side spine & pain
state: Arizona
city: Los Angeles
country: United States
facility: Nuvation Pain Group
state: California
city: Clifton
country: United States
facility: Garden State Pain Control Center
state: New Jersey
Study officials:
affiliation: Garden State Pain Control Center
name: Dipan Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Garden State Pain Control Center
name: Saurabh Dang, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Nuvation Pain Group
name: Phillip Lim, DO, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Lakeside Spine and Pain
name: Jack Diep, MD, D.ABA
role: PRINCIPAL_INVESTIGATOR
References: