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

May 18, 2026 updated by: Saluda Medical Pty Ltd

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Contact

Study Locations

  • Australia
    • Australian Capital Territory
      • Garran, Australian Capital Territory, Australia, 2605
        • Recruiting
        • ACT Pain Centre
    • New South Wales
      • Bella Vista, New South Wales, Australia, 2153
        • Recruiting
        • Sydney Pain Specialists
      • Broadmeadow, New South Wales, Australia, 2292
        • Recruiting
        • Genesis Research Services
      • Charlestown, New South Wales, Australia, 2290
        • Recruiting
        • Northern Integrated Pain Management
      • Hurstville, New South Wales, Australia, 2220
        • Recruiting
        • Australian Medical Research
      • Newtown, New South Wales, Australia, 2042
        • Recruiting
        • Inner West Pain Centre
      • Saint Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Royal North Shore Hospital
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • Northern Pain Centre
      • Sydney, New South Wales, Australia, 2000
        • Recruiting
        • Women's Health & Research Institute of Australia
      • Wahroonga, New South Wales, Australia, 2076
        • Recruiting
        • Sydney Pain Research Centre Pty Ltd
    • Queensland
      • Auchenflower, Queensland, Australia, 4066
        • Recruiting
        • Interventus Pain Specialists
      • Brisbane, Queensland, Australia, 4000
        • Recruiting
        • Axxon Pain Medicine
      • Brisbane, Queensland, Australia, 4014
        • Recruiting
        • Total Pain Clinic
      • Fortitude Valley, Queensland, Australia, 4006
        • Completed
        • QPAIN
      • Noosa, Queensland, Australia, 4567
        • Completed
        • Sunshine Coast Clinical Research
      • Peregian Beach, Queensland, Australia, 4573
        • Completed
        • Paul Frank Medical Services
      • Robina, Queensland, Australia, 4226
        • Recruiting
        • Managing Pain Clinic
    • South Australia
      • Wayville, South Australia, Australia, 5034
        • Recruiting
        • CerCare Pty Ltd
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Clinical Research
      • Doncaster East, Victoria, Australia, 3109
        • Recruiting
        • Precision Health
      • Frankston, Victoria, Australia, 3199
        • Recruiting
        • Frankston Pain Management
      • Geelong, Victoria, Australia, 3220
        • Recruiting
        • Pain Matrix
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Melbourne Pain Specialists
      • Richmond, Victoria, Australia, 3121
        • Recruiting
        • Pain Specialists Australia
    • Western Australia
      • Cottesloe, Western Australia, Australia, 6011
        • Recruiting
        • PainCare Perth

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: ECAP-controlled, closed-loop SCS
Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude
Device: Evoke Spinal Cord Stimulation (SCS) System
ECAP-controlled, closed-loop SCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Evoke Compound Action Potentials (ECAPs) as measured by the Evoke SCS System
Time Frame: Through study completion, up to 2 years
Through study completion, up to 2 years

Collaborators and Investigators

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

Sponsor

Saluda Medical Pty Ltd

Investigators

  • Study Director: Angela M Leitner, Saluda Medical Pty Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

December 15, 2020

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 4, 2020

First Posted (Actual)

December 10, 2020

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 18, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-PCL-007873

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

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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