Evoke Data Collection Study Germany
Prospective Data Collection to Evaluate the Feedback Control of the Saluda Medical's Evoke Spinal Cord Stimulation System in the Treatment of Patients With Chronic Pain of the Trunk and/or Limbs
1 other identifier
observational
2
1 country
1
Brief Summary
The objective of this multicentre study is to collect electrophysiological and device data from the Evoke Closed-Loop SCS system in the treatment of chronic pain of the trunk and/or limbs, in a real world setting under normal conditions of use.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2022
Shorter than P25 for all trials
1 active site
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
First Submitted
Initial submission to the registry
January 13, 2022
CompletedStudy Start
First participant enrolled
February 4, 2022
CompletedFirst Posted
Study publicly available on registry
March 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 17, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 17, 2022
CompletedApril 12, 2023
April 1, 2023
9 months
January 13, 2022
April 10, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
ECAP Measurement in Microvolts
Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation
through 6 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
Male and female patients, age ≥ 18 years, suffering from chronic pain in the trunk and/or limbs, whom are implanted with the Saluda Medical Evoke SCS system.
You may qualify if:
- Patient approval for data collection and transfer of de-identified data to sponsor.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universität Düsseldorf
Düsseldorf, North Rhine-Westphalia, 40225, Germany
Related Publications (1)
Nijhuis H, Kallewaard JW, van de Minkelis J, Hofste WJ, Elzinga L, Armstrong P, Gultuna I, Almac E, Baranidharan G, Nikolic S, Gulve A, Vesper J, Dietz BE, Mugan D, Huygen FJPM. Durability of Evoked Compound Action Potential (ECAP)-Controlled, Closed-Loop Spinal Cord Stimulation (SCS) in a Real-World European Chronic Pain Population. Pain Ther. 2024 Oct;13(5):1119-1136. doi: 10.1007/s40122-024-00628-z. Epub 2024 Jul 2.
PMID: 38954217DERIVED
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
January 13, 2022
First Posted
March 9, 2022
Study Start
February 4, 2022
Primary Completion
October 17, 2022
Study Completion
October 17, 2022
Last Updated
April 12, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share