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SLUHN 2016-92

Evoke Study: A Prospective, Multicenter, Randomized Double-Blind Study Examining the Safety and Efficacy of Using the Evoke™ Spinal Cord Stimulator (SCS) System with Feedback to Treat Patients with Chronic Pain of the Trunk and/or Limbs

  • Physician & Study Coordinator
  • Synopsis
  • Inclusion Criteria
  • Exclusion Criteria
  • Study Coordinator

    Susan A. Hahn

  • Synopsis: The purpose of this research is to show whether the study device, the Evoke™ Spinal Cord Stimulator System, is safe and works to treat chronic pain. This study will provide information that may help make this device more widely available to other people with chronic pain. The medical device is made by Saluda Medical.

    The Evoke System is designed to stimulate your spinal cord to potentially relieve your pain. The study device has two parts that are placed surgically (implanted): 1) the stimulator (battery pack) that is placed under the skin in the buttocks or abdomen, and 2) up to 2 leads (wires) that are inserted next to your spinal cord and connected to the stimulator. This is an investigational (experimental) device. An investigational device is one that has not been approved by the U.S. Food & Drug Administration (FDA).

    • 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.
    • 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.