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

CompletedNot applicableNCT02924129
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

Official title
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.
Interventions
  • Device: Evoke Spinal Cord Stimulator (SCS) System
Sponsor
Saluda Medical Americas, Inc.
Organization
Saluda Medical Pty Ltd
Start date
2017-01-27
Primary completion
2018-06-21
Sex
All
Age range
from 18 Years to 80 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
16

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02924129