A prospective study evaluating the safety and performance of Saluda Medical’s EvokeTM Spinal Cord Stimulation System incorporating feedback control to treat patients with chronic pain of the trunk and limbs

Saluda Medical Pty Ltd0 sites70 target enrollmentJuly 9, 2015

Overview

No summary available.

Registry

who.int

Start Date

July 9, 2015

End Date

October 14, 2019

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Saluda Medical Pty Ltd

•Patients selected for this study must meet the following inclusion criteria:
•1\. Have been diagnosed with chronic, intractable pain (VAS \= 6 for the past week), which has been refractory to conservative therapy for a minimum of 3 months.
•2\. Have been approved to undergo a trial of neural stimulation. Neural stimulation can include cervical or thoracic spinal cord stimulation.
•3\. Be an appropriate candidate for the surgical procedures required in this study based on the clinical judgment of the implanting physician
•4\. Be on a stable dose (no new, discontinued, or changes in dose) of all prescribed pain medication for at least 4 weeks prior to the trial
•5\. Be 18 years of age or older at the time of enrolment
•6\. Be willing and capable of giving written informed consent
•7\. Be willing and able to comply with study\-related requirements, procedures, and visits.
•8\. Females of childbearing age must have a negative urine pregnancy test at baseline

•Patients selected for this study must not meet the following exclusion criteria:
•1\. Have a medical condition or pain in area(s) that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator
•2\. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance with of intervention and/or ability to evaluate treatment outcomes
•3\. Are not a surgical candidate due to a diagnosis of an uncontrolled coagulation disorder, bleeding diathesis, progressive peripheral vascular disease or uncontrolled diabetes mellitus
•4\. Have an implanted pacemaker and/or another SCS system that may interfere with the Saluda system.
•5\. Have a condition currently requiring or likely to require the use of MRI or diathermy
•6\. Have a life expectancy of less than 1 year
•7\. Have an active systemic or local infection
•8\. Be allergic, or have shown hypersensitivity, to any materials of the neurostimulation system which come in contact with the body
•9\. Be pregnant or nursing (if female and sexually active, participant must be using a reliable form of birth control, be surgically sterile or be at least 2 years post\-menopausal)