EASEE® System Pivotal Study for the United States of America
NCT07301346 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2026-05-01
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
Conditions
- Drug-Resistant Focal Epilepsy
Interventions
- DEVICE
-
Implantable minimaly invasive brain stimulator
Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is activated (turned ON) for 18 months.
- DEVICE
-
Implantable minimaly invasive brain stimulator
Participants are implanted with an electrode under the skin and above the skull. The electrode is connected to an implantable pulse generator in the chest area. The system is intended for focal cortex stimulation to treat medically refractory epilepsy. The stimulation is not activated (turned OFF) for 6 months, than activated (turned ON) for 12 months.
Sponsors & Collaborators
-
Precisis US, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-07-01
- Primary Completion
- 2029-07-01
- Completion
- 2030-07-01
- FDA Device
- Yes
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