Chronic PainDomburgNCT04627974
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
An observational study of Chronic Pain, run by Saluda Medical Pty Ltd at 8 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Evoke Spinal Cord Stimulation (SCS) System
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- 8 sitesin 4 countries
- Study dates
- 5 Aug 2020to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with chronic trunk and/or limb pain.
Who may be able to join
- 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
Who cannot join
- No further exclusion criteria
Trial locations and contacts
8 sites in 4 countries.
8 sites in 4 countries
United Kingdom3 sites
Basildon University Hospital
Basildon, Essex, SS16 5NL
Southmead Hospital
Bristol, BS10 5NB
James Cook University Hospital
Middlesbrough, North Yorkshire, TS4 3BW
Belgium2 sites
AZ Delta Multidisciplinary Pain Center
Roeselare, West Flanders, 8800
AZ Nikolaas Multidisciplinary Pain Center
Sint-Niklaas, East Flanders, 9100
Netherlands2 sites
Erasmus University Medical Center
Rotterdam, 3015 GD
Rijnstate
Velp, 6815 AD
Germany1 site
Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225
About this study
Official 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
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.
- Conditions
- Chronic Pain
- Being tested
- Evoke Spinal Cord Stimulation (SCS) System
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evoke Spinal Cord Stimulation (SCS) SystemDevice
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 group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Evoke Spinal Cord Stimulation (SCS) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Visual Analogue Scale (VAS) Pain
Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable])
Measured: 3-months post-implant
Secondary outcomes (2)
Incidence of device- and procedure-related adverse events
Measured: through 60-months post-implant
Measurement of ECAPs by the Evoke SCS System
Measured: through 60-months post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2020
- Study start5 Aug 2020
- Primary completion3 Apr 2023
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saluda Medical Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04627974
- Sponsor's protocol ID
- CLIN-PLC-005299
- Acronym
- Domburg
- Status last verified
- May 2026
- First submitted
- 6 Nov 2020
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04627974
- Acronym / sponsor ID
- Domburg / CLIN-PLC-005299
- Conditions
- Chronic Pain
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Saluda Medical Pty LtdIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- 3 Apr 2023 (actual)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ECAP-controlled, closed-loop SCS | – | Device: Evoke Spinal Cord Stimulation (SCS) SystemSpinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic trunk and/or limb pain.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- No further exclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evoke Spinal Cord Stimulation (SCS) SystemA 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 | Device | ECAP-controlled, closed-loop SCS |
Primary outcome
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])
2 secondary outcomes
Incidence of device- and procedure-related adverse events
Time frame: through 60-months post-implant
Measurement of ECAPs by the Evoke SCS System
Time frame: through 60-months post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain
Recruiting
Empowered Relief® for Cancer Survivors With Chronic Pain
Chronic Pain Due to Cancer, Pain Catastrophizing
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pain, run by Saluda Medical Pty Ltd at 8 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United Kingdom, Belgium, Netherlands, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Visual Analogue Scale (VAS) Pain (time frame: 3-months post-implant). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.