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
Chronic Pain
What this study involves
The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.
- Study type
- Observational
- Phase
- Not applicable / not listed
- Age range
- Not specified - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Not accepted
- Participants
- 70 Actual
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
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.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
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 population
Patients with chronic trunk and/or limb pain.
Understand screeningTreatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Not reported
- Masking
- Not reported
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
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
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
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 measures
Incidence of device- and procedure-related adverse events
Time frame: through 60-months post-implant
Not reported in this registry record.
Measurement of ECAPs by the Evoke SCS System
Time frame: through 60-months post-implant
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (8)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
8 locations
AZ Nikolaas Multidisciplinary Pain CenterSint-Niklaas, East Flanders, BelgiumStatus unknown
AZ Delta Multidisciplinary Pain CenterRoeselare, West Flanders, BelgiumStatus unknown
Universität DüsseldorfDüsseldorf, North Rhine-Westphalia, GermanyStatus unknown
Erasmus University Medical CenterRotterdam, NetherlandsStatus unknown
RijnstateVelp, NetherlandsStatus unknown
Basildon University HospitalBasildon, Essex, United KingdomStatus unknown
James Cook University HospitalMiddlesbrough, North Yorkshire, United KingdomStatus unknown
Southmead HospitalBristol, United KingdomStatus unknown
Study team and timeline
- Lead sponsor
- Saluda Medical Pty Ltd
- Study start
- Aug 5, 2020 Actual
- Primary completion
- Apr 3, 2023 Actual
- Study completion
- Dec 31, 2028 Estimated
- First posted
- Nov 13, 2020 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
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
Ask Wellness Clinical Research
Your message goes to WCR, including when this study is run by another organization. WCR may offer general guidance but may not operate this trial, have access to its team or be able to enroll you.
Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026