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Clinical Trials in the Netherlands / NCT04627974
Active, not recruiting Observational

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

NCT04627974 · tracked via the Priya Life Science Netherlands tracker
Sponsor
Saluda Medical Pty Ltd
Phase
Observational
Started
2020-08-05
Last updated
2026-05-15

Condition(s) studied

Chronic Pain

Investigational drug(s) / intervention(s)

Evoke Spinal Cord Stimulation (SCS) System

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

Study summary

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.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Percent Change in Visual Analogue Scale (VAS) Pain — 3-months post-implant
    Visual Analogue Scale (VAS) to rate pain intensity (0mm \[no pain\] to 100mm \[worst pain imaginable\])

Trial sites (8)

FacilityCityRegionStatus
AZ Nikolaas Multidisciplinary Pain Center Sint-Niklaas East Flanders
AZ Delta Multidisciplinary Pain Center Roeselare West Flanders
Universität Düsseldorf Düsseldorf North Rhine-Westphalia
Erasmus University Medical Center Rotterdam Netherlands
Rijnstate Velp Netherlands
Basildon University Hospital Basildon Essex
James Cook University Hospital Middlesbrough North Yorkshire
Southmead Hospital Bristol United Kingdom

Other trials for the same condition

Pain Predict Genetics Active, not recruiting
Patient Retrospective Outcomes (PRO) Recruiting
Natural Course of Pain Following Surgery Through an Abdominal Incision Active, not recruiting
Long-Term Real-World Outcomes Study on Patients Implanted With a Neurostimulator Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04627974 on ClinicalTrials.gov ↗ ← All trials in the Netherlands