Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-25 @ 3:47 AM
NCT ID:
NCT06340802
Brief 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.
Study:
NCT06340802
Study Brief:
Protocol Section:
NCT06340802