Evoke Data Collection Study Germany

Completed

• Conditions: Chronic Pain
• Interventions: Device: Evoke Spinal Cord Stimulation (SCS) System

• Registration Number: NCT05272137
• Lead Sponsor: Saluda Medical Pty Ltd

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-13
• Study Start: 2022-02-04
• Study First Submitted QC: 2022-03-08
• Study First Posted: 2022-03-09
• Primary Completion: 2022-10-17
• Study Completion: 2022-10-17
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-10
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2

Inclusion Criteria

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

Exclusion Criteria

• No further exclusion criteria.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ECAP-controlled, closed-loop SCS	Evoke Spinal Cord Stimulation (SCS) System	Spinal cord stimulation that measures and records evoked compound action potentials (ECAPs) and automatically adjusts the stimulation current to maintain a consistent ECAP amplitude

Primary Outcome Measures

Name	Time	Method
ECAP Measurement in Microvolts	through 6 months post-implant	Evoked Compound Action Potentials (ECAPs) as a measure of spinal cord activation

Trial Locations

Locations (1)

Universität Düsseldorf; 🇩🇪 Düsseldorf, North Rhine-Westphalia, Germany