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

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ClinicalTrials.gov Identifier: NCT02924129
Recruitment Status : Active, not recruiting
First Posted : October 5, 2016
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chronic Pain Back Pain Pain Device: Evoke Spinal Cord Stimulator (SCS) System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 134 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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.
Actual Study Start Date : January 16, 2017
Actual Primary Completion Date : June 21, 2018
Estimated Study Completion Date : May 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chronic Pain

Arm Intervention/treatment
Experimental: Evoke SCS with Feedback
closed-loop/automatic stimulation
Device: Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

Active Comparator: Evoke SCS with Conventional
open-loop/manual stimulation
Device: Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).




Primary Outcome Measures :
  1. Change from Baseline in overall trunk and limb VAS pain score and pain medications [ Time Frame: 3 months ]
    The primary endpoint is a composite endpoint. A success is defined as a reduction in overall trunk and limb VAS pain score greater than or equal to 50 percent and no increase in baseline pain medication.


Secondary Outcome Measures :
  1. Change from Baseline in overall trunk and limb VAS pain score [ Time Frame: 3 and 12 months ]
  2. Change from Baseline in back VAS pain score [ Time Frame: 3 and 12 months ]
  3. Change from Baseline in leg VAS pain score [ Time Frame: 3 and 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02924129


Locations
United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85027
Arizona Pain Specialists
Scottsdale, Arizona, United States, 85258
United States, California
Summit Pain Alliance
Santa Rosa, California, United States, 95401
Thrive Clinic
Santa Rosa, California, United States, 95403
IPM Medical Group
Walnut Creek, California, United States, 94598
United States, Missouri
Pain Management Associates
Lee's Summit, Missouri, United States, 64086
United States, New Jersey
Premier Pain Centers
Shrewsbury, New Jersey, United States, 07702
United States, New York
Ainsworth Institute of Pain Management
New York, New York, United States, 10022
United States, North Carolina
Center for Clinical Research
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Integrated Pain Solutions
Columbus, Ohio, United States, 43240
United States, Pennsylvania
St. Luke's University Health Network
Bethlehem, Pennsylvania, United States, 18015
Delaware Valley Pain & Spine Institute
Feasterville-Trevose, Pennsylvania, United States, 19053
United States, West Virginia
Center for Pain Relief
Charleston, West Virginia, United States, 25301
United States, Wisconsin
Advanced Pain Management
Greenfield, Wisconsin, United States, 53221
Sponsors and Collaborators
Saluda Medical Americas, Inc.
Investigators
Study Director: Dan Brounstein, MBA Saluda Medical Americas, Inc.

Responsible Party: Saluda Medical Americas, Inc.
ClinicalTrials.gov Identifier: NCT02924129     History of Changes
Other Study ID Numbers: SCLSH1503
First Posted: October 5, 2016    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. ):
Chronic Pain
Back Pain
Leg Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
SCS
Closed Loop

Additional relevant MeSH terms:
Back Pain
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms