Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation (EVOKE)

Saluda Medical

Status: Completed

Conditions: Back Pain; Chronic Pain; Pain

Treatments: Device: Evoke Spinal Cord Stimulator (SCS) System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02924129

SCLSH1503

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy of the Saluda Medical Evoke SCS System with feedback control to treat chronic pain of the trunk and/or limbs.

Enrollment: 134 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject is male or female between the ages of 18 and 80 years.
• Have been diagnosed with chronic, intractable pain of the trunk and/or limbs, which has been refractory to conservative therapy for a minimum of 6 months.
• Be an appropriate candidate for an SCS trial and the surgical procedures required in this study based on the clinical judgment of the Investigator.
• Be willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits.

Exclusion criteria

• Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, 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.
• Have an active systemic infection or local infection in the area of the surgical site.
• Be pregnant or nursing (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile, or be at least 2 years post-menopausal).
• Be concomitantly participating in another clinical study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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134 participants in 2 patient groups

Evoke SCS with Feedback

Experimental group

Description:

closed-loop/automatic stimulation

Treatment:

Device: Evoke Spinal Cord Stimulator (SCS) System

Evoke SCS with Conventional

Active Comparator group

Description:

open-loop/manual stimulation

Treatment:

Device: Evoke Spinal Cord Stimulator (SCS) System