Safety and Efficacy Study of the Evoke™ SCS System With Feedback vs. Conventional Stimulation
Status: | Active, not recruiting |
---|---|
Conditions: | Back Pain, Chronic Pain, Chronic Pain, Chronic Pain |
Therapuetic Areas: | Musculoskeletal |
Healthy: | No |
Age Range: | 18 - 80 |
Updated: | 7/1/2018 |
Start Date: | January 16, 2017 |
End Date: | May 2021 |
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.
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.
SCS System with feedback control to treat chronic pain of the trunk and/or limbs.
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.
We found this trial at
16
sites
4979 Old Street Road
Feasterville-Trevose, Pennsylvania 19053
Feasterville-Trevose, Pennsylvania 19053
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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