NCT07301346Not yet recruiting
EASEE® System Pivotal Study for the United States of America
Source: ClinicalTrials.gov · Last updated 28 Aug 2026
Brief summary (registry, in English)
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
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 27 Nov 2025
- Start date
- 31 Oct 2026
- Primary completion date
- 1 Nov 2029
- Lead sponsor
- Precisis US, Inc.
- Diseases
- Epilepsy
- NCT number
- NCT07301346
What you commit to
- Study type: Interventional
- Planned participants: 200
- From 31 Oct 2026 to the primary completion date, 1 Nov 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Diagnostic of non-epileptic seizures
- Active idiopathic generalized epilepsy
- Clinically significant or unstable medical condition
Other
- Recent status epileptics (\<12 months)
- Active psychosis, major depression, suicidal ideation (\<6 months)
- Pregnancy
- Implanted with brain stimulation device or active Vagus Nerve Stimulation
Who the study is looking for
- Adult between 18-75 years of age
- Diagnosis of drug-resistant focal epilepsy
- At least four (4) observable seizure manifestations per month
- Stable anti-seizure medication regimen
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Columbia University Irving Medical Center/New York Presbyterian Hospital Coordinator of this site? Confirm its status | New York | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.