EASEE® System Pivotal Study for the United States of America

The goal of this clinical trial is to demonstrate the safety and effectiveness of focal cortex stimulation with the EASEE(R) System in a large cohort of subjects with medically refractory focal epilepsy. The main questions it aims to answer are: 1. Is the percentage reduction of monthly seizure rate larger in the Intervention group than in the Control group at the end of the Blinded Phase? 2. Is the use of EASEE(R) System safe after up to 28 and up to 84 days? Participants will be asked to: * Complete a seizure diary for the duration of the clinical trial * Attend study visits for 20 months of their clinical trial participation * Undergo EASEE(R) System implant * Not be aware if neurostimulation is delivered during the Blinded Phase (6 months) * Receive neurostimulation for at least 12 months

NCT Number	NCT07301346
Lead Sponsor	Precisis US, Inc.
Conditions	Drug-Resistant Focal Epilepsy
Enrollment	200 participants
Start Date	2026-07-01
Primary Completion	2029-07-01 (estimated)
Study Completion	2030-07-01 (estimated)
Updated on ClinicalTrials.gov	2026-05-01