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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

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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

Evoke Spinal Cord Stimulation System

Device

ECAP-controlled closed loop with investigational programming software module, the Assisted Programming Module (APM)

Primary outcomes

  1. Succsessful Use of APM

    Time frame: All timepoints through study completion, on average 3-months post-implant procedure.

    Of all APM uses, the workflow was able to generate a closed-loop program 134 (96%) times.

Secondary outcomes

  1. Time to Generate APM Program When Closed-loop Program Achieved

    Time frame: All uses through study completion in which APM was initiated

    The time (minutes) for the APM to generate a closed-loop program

Interested in participating?

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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
Sep 25, 2026

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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