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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Visual Analogue Scale (VAS) Pain | Visual Analogue Scale (VAS) to rate pain intensity (0mm [no pain] to 100mm [worst pain imaginable]) | 3-months post-implant |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of device- and procedure-related adverse events | through 60-months post-implant | |
| Measurement of ECAPs by the Evoke SCS System | through 60-months post-implant |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic trunk and/or limb pain.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AZ Nikolaas Multidisciplinary Pain Center | Sint-Niklaas | East Flanders | 9100 | Belgium | ||
| AZ Delta Multidisciplinary Pain Center |
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| Roeselare |
| West Flanders |
| 8800 |
| Belgium |
| Universität Düsseldorf | Düsseldorf | North Rhine-Westphalia | 40225 | Germany |
| Erasmus University Medical Center | Rotterdam | 3015 GD | Netherlands |
| Rijnstate | Velp | 6815 AD | Netherlands |
| Basildon University Hospital | Basildon | Essex | SS16 5NL | United Kingdom |
| James Cook University Hospital | Middlesbrough | North Yorkshire | TS4 3BW | United Kingdom |
| Southmead Hospital | Bristol | BS10 5NB | United Kingdom |
| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062187 | Spinal Cord Stimulation |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D004358 | Drug Therapy |
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