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A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl — AURORA  

Drug Resistant Epilepsy Clinical Trial

Official title:
A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl

Clinical Trial Summary

This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.

Clinical Trial Description

This is the first clinical investigation with the NAO.VNS SYSTEM from Synergia Medical. Up to 10 patients with drug resistant epilespy, who are eligible for vagus nerve stimulation, will be included in two sites. The total duration of the study is expected to be 36 months. Study procedures are composed of (i) baseline, (ii) implantation, (iii) titration and (iv) follow-up until 24 months. Primary objective is to evaluate safety of the NAO.VNS SYSTEM. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06340802
Study type Interventional
Source Synergia Medical
Contact Catherine Léonard, PhD
Phone +32473290006
Email catherine.leonard@synergiam.com
Status Not yet recruiting
Phase N/A
Start date June 2024
Completion date December 2026
View Details
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