NCT06340802

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

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: Synergia Medical · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Drug Resistant Epilepsy

Interventions

Type	Name	Description
DEVICE	VNS Treatment	Vagus nerve stimulation is started 2-week after the implantation

Timeline

• Start date: 2024-08-06
• Primary completion: 2025-01-06
• Completion: 2026-10-01
• First posted: 2024-04-02
• Last updated: 2025-06-25

Locations

3 sites across 2 countries: Belgium, Germany