Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340802
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-21
Brief Title:
A First in HUman Study for Resistant Epilepsy with the Vagus Nerve StimulatiOn Device by SyneRgia MedicAl
Sponsor:
Synergia Medical
Organization:
Synergia Medical
Study Overview
Official Title:
A First in HUman Study for Resistant Epilepsy with the Vagus Nerve StimulatiOn Device by SyneRgia MedicAl
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AURORA
Brief Summary:
This is an open label single arm interventional prospective first in human study designed to evaluate the safety of the NAOVNS SYSTEM
Detailed Description:
This is the first clinical investigation with the NAOVNS 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 NAOVNS SYSTEM
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 NAOVNS SYSTEM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None