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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
Sponsor: Saluda Medical Pty Ltd
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.
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
Key Details
Gender
All
Age Range
Any - Any
Study Type
OBSERVATIONAL
Enrollment
70
Start Date
2020-08-05
Completion Date
2027-12-31
Last Updated
2024-07-05
Healthy Volunteers
No
Conditions
Interventions
Evoke Spinal Cord Stimulation (SCS) System
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
Locations (8)
AZ Nikolaas Multidisciplinary Pain Center
Sint-Niklaas, East Flanders, Belgium
AZ Delta Multidisciplinary Pain Center
Roeselare, West Flanders, Belgium
Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, Germany
Erasmus University Medical Center
Rotterdam, Netherlands
Rijnstate
Velp, Netherlands
Basildon University Hospital
Basildon, Essex, United Kingdom
James Cook University Hospital
Middlesbrough, North Yorkshire, United Kingdom
Southmead Hospital
Bristol, United Kingdom