Recruiting

Evoke® CL-SCS

Sponsor:

Saint Francis Hospital

Code:

NCT06246526

Conditions

Pain

Chronic Pain

Neuropathic Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evoke

Study Details

Brief summary:

This observational, prospective data collection is designed to evaluate the efficacy of CL-SCS therapy in real-world patients suffering from chronic pain.

Conditions

Pain

Chronic Pain

Neuropathic Pain

Study ID

NCT06246526

Start date

Jan 30, 2024

Status verified date

Jun, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

Be 18 years of age or older at the time of enrollment.

Diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.

Subject has a minimum Visual Analog Scale (VAS) score of 60 mm or higher (where 100 mm indicates the worst imaginable pain) at baseline.

Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician.

Be willing and capable of giving informed consent.

Be willing and able to comply with study-related requirements, procedures, and visits.

Exclusion Criteria:

Subject is pregnant or nursing.

Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, as determined by the Investigator.

Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention, and/or ability to evaluate treatment outcomes.

Have an existing drug pump and/or SCS system or another active implantable device such as a pacemaker, deep brain stimulator (DBS), or sacral nerve stimulator (SNS).

Have prior experience with SCS.

Be concomitantly participating in another clinical study.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Interventions

Evoke

The Saluda Medical Evoke® CL-SCS System (Evoke System). The Evoke System measures and records spinal cord (SC) activation resulting from stimulation via evoked compound action potentials (ECAPs). The Evoke System can be programmed to provide ECAP-controlled, closed-loop SCS or open-loop, fixed-output (traditional) SCS; ECAPs may be measured and recorded in either stimulation mode.

Primary outcome measure

  • VAS - Visual Analog Scale [ Time Frame: Baseline to 12 months ]

Central Contacts and Locations

Central contacts

Locations

The Spine and Nerve Center of Saint Francis Hospital

Recruiting

Charleston, West Virginia, United States, 25301

Contacts

More Information

Sponsor

Saint Francis Hospital

Last update posted

Jun 23, 2026

Last verified

Jun, 2026

Keywords

  • Saluda
  • Spinal Cord Stimulation

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Saint Francis Hospital on 2026-06-23.