Novel Treatment Delivery of ECAP-controlled Closed-loop SCS for Chronic Pain

The purpose of this study is to test and evaluate novel treatment delivery of ECAP-controlled closed loop SCS through the incorporation of new software and/or hardware features for patients with the Evoke System.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain 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

ACT Pain Centre, Garran, Australian Capital Territory, Australia

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1. Subject has undergone trial implant or is planning to be implanted with the Evoke System within its approved indication.
2. Subject is willing and capable of giving informed consent and able to comply with study-related requirements.

Exclusion criteria

N/A

Treatment and study plan

Evoke Spinal Cord Stimulation (SCS) System

Device

ECAP-controlled, closed-loop SCS

Primary outcomes

Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System

Time frame: Through study completion, up to 2 years

Study contacts

Contact information is provided by the study sponsor or research team.

Director, Clinical Affairs

CONTACT

[email protected]

16512084223

Sponsors and collaborators

Lead sponsor

Saluda Medical Pty Ltd

Industry

Registry information

Official study title

A Prospective, Multicentre, Single-arm Feasibility Study Examining Novel Treatment Delivery of the Evoke Spinal Cord Stimulator (SCS) System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

Acronym: Freshwater

Important dates

Study start: 2020
Primary completion: 2027
Study completion: 2027
First posted: Dec 10, 2020
Registry last updated: May 19, 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.

Published trials that share one or more normalized conditions with this study.

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