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

Completed · Not applicable

Conditions studied: Chronic Pain, Back Pain, Pain

In brief

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.

Key facts

Study ID

NCT02924129

Run by

Saluda Medical Americas, Inc.

People needed

134

Starts

2017-01-27

Expected to finish

2022-09-09

Last updated by the study team

2024-01-03

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Hope Research Institute — Phoenix, Arizona, United States
• Arizona Pain Specialists — Scottsdale, Arizona, United States
• Summit Pain Alliance — Santa Rosa, California, United States
• Thrive Clinic — Santa Rosa, California, United States
• IPM Medical Group — Walnut Creek, California, United States
• Pain Management Associates — Lee's Summit, Missouri, United States
• Premier Pain Centers — Shrewsbury, New Jersey, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• Center for Clinical Research — Winston-Salem, North Carolina, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• Integrated Pain Solutions — Columbus, Ohio, United States
• St. Luke's University Health Network — Bethlehem, Pennsylvania, United States
• Delaware Valley Pain & Spine Institute — Feasterville-Trevose, Pennsylvania, United States
• Center for Pain Relief — Charleston, West Virginia, United States
• Advanced Pain Management — Greenfield, Wisconsin, United States

Full record on ClinicalTrials.gov

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