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

Launched by SALUDA MEDICAL AMERICAS, INC. · Oct 3, 2016

Keywords

ClinConnect Summary

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Gender

ALL

Eligibility criteria

• 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 Officials