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OpenTrials
Completed

NCT Number: NCT06057480

APM in the Evoke 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.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pain, Chronic Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APM

Device

Investigational programming software module, the Assisted Programming Module (APM)

Primary outcomes

  1. 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

  2. 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

Sponsors and collaborators

Lead sponsor

Saluda Medical Pty Ltd

Industry

Registry information

Official study title

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

Acronym: APM

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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