EASEE® System Pivotal Study for the United States of America
Part of paid clinical trials in New York, New York.
- Sponsor
- Precisis US, Inc.
- Study ID
- NCT07301346
- Status
- Not Yet Recruiting
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Conditions
- Drug-Resistant Focal Epilepsy
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Implantable minimaly invasive brain stimulator — DEVICEParticipants 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.
- Implantable minimaly invasive brain stimulator — DEVICEParticipants 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.
Study Details
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
Key Dates
- First listed
- Dec 24, 2025
- Start date
- Oct 31, 2026
- Status verified
- Aug 2026
- Primary completion
- Nov 1, 2029
- Completion
- Nov 1, 2030
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Intervention groupParticipants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.
- Sham Comparator: Control groupParticipants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.
Primary Outcome Measure
Percentage reduction in the monthly seizure rate [Effectiveness] [ Time Frame: Baseline and months 5 and 6 ]
Central Contacts
- Perry Rice+49 6221 6559321
- Aude Yulzari+49 6221 6559321
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Columbia University Irving Medical Center/New York Presbyterian Hospital | New York | New York | 10032 |