Long-term Effectiveness, Safety, and Performance of the Evoke Closed-Loop SCS System to Treat Patients With Chronic Pain of the Trunk and/or Limbs (Domburg)

May 12, 2026 updated by: Saluda Medical Pty Ltd

A Prospective Study to Evaluate the Long-term Effectiveness, Safety, and Performance of the Saluda Medical's EvokeTM Closed-Loop Spinal Cord Stimulation System to Treat Patients With Chronic Pain of the Trunk and/or Limbs

The objective of this multicountry, multicentre, prospective study is to evaluate the long-term clinical effectiveness, safety, and performance of the Evoke System in the treatment of chronic pain of the trunk and/or limbs in a real-world population.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

70

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

  • Belgium
    • East Flanders
      • Sint-Niklaas, East Flanders, Belgium, 9100
        • AZ Nikolaas Multidisciplinary Pain Center
    • West Flanders
      • Roeselare, West Flanders, Belgium, 8800
        • AZ Delta Multidisciplinary Pain Center
  • Germany
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germany, 40225
        • Universität Düsseldorf
  • Netherlands
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus University Medical Center
      • Velp, Netherlands, 6815 AD
        • Rijnstate
  • United Kingdom
      • Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital
    • Essex
      • Basildon, Essex, United Kingdom, SS16 5NL
        • Basildon University Hospital
    • North Yorkshire
      • Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW
        • James Cook University Hospital

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic trunk and/or limb pain.

Description

Inclusion Criteria:

  • Eligible for therapy according to the Evoke System indications for use statement and labelling requirements
  • Willing and capable of giving informed consent and able to comply with study-related requirements, procedures, and visits
  • Baseline VAS pain rating ≥60 mm in the primary area of pain

Exclusion Criteria:

  • No further 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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
A spinal cord stimulation system that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Visual Analogue Scale (VAS) Pain
Time Frame: 3-months post-implant
Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])
3-months post-implant

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of device- and procedure-related adverse events
Time Frame: through 60-months post-implant
through 60-months post-implant
Measurement of ECAPs by the Evoke SCS System
Time Frame: through 60-months post-implant
through 60-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)

August 5, 2020

Primary Completion (Actual)

April 3, 2023

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

November 6, 2020

First Submitted That Met QC Criteria

November 11, 2020

First Posted (Actual)

November 13, 2020

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLIN-PLC-005299

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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