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Clinical Trial

EASEE® System Pivotal Study for the United States of America

NCT: NCT07301346 · NOT_YET_RECRUITING

NCT IDNCT07301346
StatusNOT_YET_RECRUITING
Start Date2026-07-01
Completion2030-07-01

Brief Summary

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

Frequently Asked Questions

What is EASEE® System Pivotal Study for the United States of America?

EASEE® System Pivotal Study for the United States of America is a clinical trial registered under NCT07301346. Current status: NOT_YET_RECRUITING.

What is the status of NCT07301346?

The current status of NCT07301346 (EASEE® System Pivotal Study for the United States of America) is: NOT_YET_RECRUITING.

When did EASEE® System Pivotal Study for the United States of America start?

EASEE® System Pivotal Study for the United States of America started on 2026-07-01.

Official Source

View on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov API. For the most current status, refer to the official record.