Evoke Data Collection Study Germany

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.

Completed

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Key information

Conditions

Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patient approval for data collection and transfer of de-identified data to sponsor.

Exclusion criteria

No further exclusion criteria.

Treatment and study plan

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

Primary outcomes

ECAP Measurement in Microvolts

Time frame: through 6 months post-implant

Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation

Sponsors and collaborators

Lead sponsor

Saluda Medical Pty Ltd

Industry

Registry information

Official study 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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Mar 9, 2022
Registry last updated: Apr 12, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed