Fig 1.
Essentially, the screening period is set at 30 days and the investigational testing period after insertion is a maximum of 2 weeks to facilitate testing and provide sufficient time for non-provoked spontaneous seizures to occur. The post-observation period (1 week) is judged as sufficient for monitoring potential adverse events associated with endovascular and intracranial implantation of electrodes. *Not required if epileptic seizures occur within one week of placement of the test device. ** EP-01 will be left in place until the onset of epileptic seizures or for a maximum of 14 days (plus 3 days). ***If the trial is to be stopped during the clinical trial inspection period, the tests specified at the time of removal of the EP-01 will be carried out as much as possible depending on the subject’s condition, the EP-01 will be removed, and the trial will move to the post-observation period. Suppose the trial is to be stopped during the post-observation period. In that case, the tests specified one week after removal of the test device will be carried out as much as possible depending on the subject’s condition, and the trial will then end. **** Only subjects who underwent epilepsy resection were included. ***** If the measurement is conducted within 90 days before obtaining consent, there is no need to remeasure, and data from before consent was obtained will be collected. ****** When only EP-01 or both EP-01 and intracranial electrodes are indwelled, EEG data from EP-01 and intracranial electrodes will be recorded under video surveillance. EEG data during eyes opening and closing (the investigator, etc. will decide the timing of EEG data acquisition during eyes opening and closing) and EEG data during epileptic seizures will be submitted to the Central Evaluation Committee.