Evoke Data Collection Study Germany

NCT ID: NCT05272137

Last Updated: 2023-04-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-04

Study Completion Date

2022-10-17

Brief Summary

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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

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Conditions

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Chronic Pain

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

Evoke Spinal Cord Stimulation (SCS) System

Intervention Type 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

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Patient approval for data collection and transfer of de-identified data to sponsor.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Saluda Medical Pty Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Universität Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 38954217 (View on PubMed)

Other Identifiers

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D100967

Identifier Type: -

Identifier Source: org_study_id

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