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NCT05272137 Clinical Trial

Evoke Data Collection Study Germany

Chronic Pain Clinical Trial

Official title:
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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05272137
Other study ID # D100967
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 4, 2022
Est. completion date October 17, 2022

Study information
Verified date April 2023
Source Saluda Medical Pty Ltd
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 2
Est. completion date October 17, 2022
Est. primary completion date October 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient approval for data collection and transfer of de-identified data to sponsor. Exclusion Criteria: - No further exclusion criteria.

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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
Country Name City State
Germany Universität Düsseldorf Düsseldorf North Rhine-Westphalia

Sponsors (1)
Lead Sponsor Collaborator
Saluda Medical Pty Ltd

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary ECAP Measurement in Microvolts Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation through 6 months post-implant
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