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
Domburg
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
1 other identifier
observational
70
4 countries
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Aug 2020
Longer than P75 for all trials
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2020
CompletedFirst Submitted
Initial submission to the registry
November 6, 2020
CompletedFirst Posted
Study publicly available on registry
November 13, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 3, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
ExpectedJuly 5, 2024
July 1, 2024
2.7 years
November 6, 2020
July 2, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (2)
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
Study Arms (1)
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
Interventions
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
Eligibility Criteria
Patients with chronic trunk and/or limb pain.
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
AZ Nikolaas Multidisciplinary Pain Center
Sint-Niklaas, East Flanders, 9100, Belgium
AZ Delta Multidisciplinary Pain Center
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
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 6, 2020
First Posted
November 13, 2020
Study Start
August 5, 2020
Primary Completion
April 3, 2023
Study Completion (Estimated)
December 31, 2027
Last Updated
July 5, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share