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

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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.


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
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200 Northeast Missouri Road
Lee's Summit, Missouri 64086
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Bethlehem, Pennsylvania
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Charleston, West Virginia 25301
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Columbus, Ohio 43219
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4979 Old Street Road
Feasterville-Trevose, Pennsylvania 19053
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Greenfield, Wisconsin 53221
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New York, New York 10022
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Phoenix, Arizona 85050
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Santa Rosa, California 95401
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Santa Rosa, California 95403
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Scottsdale, Arizona 85258
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Shrewsbury, New Jersey 07702
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Walnut Creek, California 94598
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Winston-Salem, North Carolina 27103
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