APM in the Evoke SCS System to Program Patients With Chronic Pain of the Trunk and/or Limbs (APM)

May 12, 2025 updated by: Saluda Medical Pty Ltd

A Prospective, Multicenter, Single-arm Study Examining the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to Program Patients With Chronic Pain of the Trunk and/or Limbs

Study to evaluate the use of the Assisted Programming Module (APM) in the Evoke Spinal Cord Stimulation (SCS) System to program patients with chronic pain of the trunk and/or limbs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • California
      • Santa Rosa, California, United States, 95403
        • Pacific Research Institute
    • Florida
      • Gainesville, Florida, United States, 32607
        • The Orthopaedic Institute, PA
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27103
        • Center for Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has or is planning to undergo a temporary trial with Evoke System within the FDA approved indication.
  • Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion Criteria:

  • There are no exclusion criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: APM
Investigational programming software module, the Assisted Programming Module (APM)
Device: APM
Investigational programming software module, the Assisted Programming Module (APM)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
Time Frame: end of trial period; 1 month and 3 months post-implant
Change in Evoked Compound Action Potentials (ECAPs) measured in µV by the Evoke SCS System
end of trial period; 1 month and 3 months post-implant
Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System
Time Frame: end of trial period; 1 month and 3 months post-implant
Change in programming parameters (e.g., stimulation frequency [Hz], pulse width [µs], amplitude [mA]) measured by the Evoke SCS System
end of trial period; 1 month and 3 months post-implant

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saluda Medical Pty Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 26, 2023

Primary Completion (Actual)

December 19, 2024

Study Completion (Actual)

December 19, 2024

Study Registration Dates

First Submitted

September 15, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 15, 2025

Last Update Submitted That Met QC Criteria

May 12, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D103684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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