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

Pain Clinical Trial

— EVOKE  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02924129
• Other study ID #: SCLSH1503
• Status: Completed
• Phase: N/A
• Start date: January 27, 2017
• Est. completion date: September 9, 2022

Study information

• Verified date: December 2023
• Source: Saluda Medical Pty Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: September 9, 2022
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Chronic Pain
• Pain

Intervention

Device:
• Evoke Spinal Cord Stimulator (SCS) System
Spinal Cord Stimulation that measures and records evoked compound action potentials (ECAPs).

Locations

Country	Name	City	State
United States	St. Luke's University Health Network	Bethlehem	Pennsylvania
United States	Center for Pain Relief	Charleston	West Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Integrated Pain Solutions	Columbus	Ohio
United States	Delaware Valley Pain & Spine Institute	Feasterville-Trevose	Pennsylvania
United States	Advanced Pain Management	Greenfield	Wisconsin
United States	Pain Management Associates	Lee's Summit	Missouri
United States	Ainsworth Institute of Pain Management	New York	New York
United States	Hope Research Institute	Phoenix	Arizona
United States	Summit Pain Alliance	Santa Rosa	California
United States	Thrive Clinic	Santa Rosa	California
United States	Arizona Pain Specialists	Scottsdale	Arizona
United States	Premier Pain Centers	Shrewsbury	New Jersey
United States	IPM Medical Group	Walnut Creek	California
United States	Center for Clinical Research	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Saluda Medical Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Composite Endpoint Success	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. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Secondary	Percent Change From Baseline in Leg Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Secondary	Percent Change From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Secondary	Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	3 months
Secondary	Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	3 months
Secondary	Number of Participants With Composite Endpoint Success	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. VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain.	12 months
Secondary	Percent Change From Baseline in Leg Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Secondary	Percent Change From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Secondary	Proportion of Subjects With Greater Than or Equal to 80% Reduction From Baseline in Overall Trunk and Limb Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months
Secondary	Proportion of Subjects With Greater Than or Equal to 50% Reduction From Baseline in Back Pain VAS Score	VAS = Visual Analog Scale, from 0 to 100 mm, where 0 = no pain and 100 = worst imaginable pain	12 months