A First in hUman Study for Resistant Epilepsy With the Vagus Nerve stimulatiOn Device by syneRgia medicAl
NCT06340802 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2025-06-25
Summary
This is an open label, single arm, interventional, prospective first in human study, designed to evaluate the safety of the NAO.VNS SYSTEM.
Conditions
- Drug Resistant Epilepsy
Interventions
- DEVICE
-
VNS Treatment
Vagus nerve stimulation is started 2-week after the implantation
Sponsors & Collaborators
-
Synergia Medical
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-08-06
- Primary Completion
- 2025-01-06
- Completion
- 2026-10-31
Countries
- Belgium
- Germany
Study Locations
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