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NCT Number: NCT04627974

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Observational

Primary location

AZ Nikolaas Multidisciplinary Pain Center, Sint-Niklaas, East Flanders, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Evoke Spinal Cord Stimulation (SCS) System

Device

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

Primary outcomes

  1. 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])

Secondary outcomes

  1. Incidence of device- and procedure-related adverse events

    Time frame: through 60-months post-implant

  2. Measurement of ECAPs by the Evoke SCS System

    Time frame: through 60-months post-implant

Sponsors and collaborators

Lead sponsor

Saluda Medical Pty Ltd

Industry

Registry information

Official study title

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

Acronym: Domburg

Important dates

Study start
2020
Primary completion
2023
Study completion
2028
First posted
Nov 13, 2020
Registry last updated
May 15, 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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