EASEE® System - Long-term registry on Epilepsy Evolution in subjects treated with transcranial focal cortex stimulation - EASEE-LEE

Precisis GmbH0 个研究点目标入组 40 人开始时间: 2023年8月29日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•1.Subject who meets the indication for use of the EASEE® System and with an implant procedure scheduled within the next quarter,
•OR subject previously enrolled in one of the clinical investigations EASEE II or PIMIDES I and currently implanted with an EASEE® System.
•2.Subject with observable manifestation of distinct seizures which are stereotypical events and can be reliably counted, in the opinion of the Investigator, by the patient or a caregiver and which can be reliably recorded in a seizure diary
•3.Subject willing to complete a seizure diary and share it with the investigator
•4.Subject able and willing to provide written informed consent
•5.Subjects with a life expectancy = 15 months
•6.Subject not participating in any interventional study (drug, device, food regimen)

发起方

Precisis GmbH