We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 83 for:    EVOKE
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified September 2017 by Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. )
Sponsor:
ClinicalTrials.gov Identifier:
NCT02924129
First Posted: October 5, 2016
Last Update Posted: November 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. )
  Purpose
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 Intervention
Chronic Pain Back Pain Pain Device: Evoke Spinal Cord Stimulator (SCS) System

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by Saluda Medical Pty Ltd ( Saluda Medical Americas, Inc. ):

Primary Outcome Measures:
  • 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:
  • Change from Baseline in overall trunk and limb VAS pain score [ Time Frame: 3 and 12 months ]
  • Change from Baseline in back VAS pain score [ Time Frame: 3 and 12 months ]
  • Change from Baseline in leg VAS pain score [ Time Frame: 3 and 12 months ]

Estimated Enrollment: 134
Actual Study Start Date: January 16, 2017
Estimated Study Completion Date: May 2021
Estimated Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
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.
  Contacts and Locations
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


Contacts
Contact: Dan Brounstein, MBA 650-703-8436 dan.brounstein@saludamedical.com

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

Responsible Party: Saluda Medical Americas, Inc.
ClinicalTrials.gov Identifier: NCT02924129     History of Changes
Other Study ID Numbers: SCLSH1503
First Submitted: September 30, 2016
First Posted: October 5, 2016
Last Update Posted: November 6, 2017
Last Verified: September 2017
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