EASEE® System Pivotal Study for the United States of America (EASEE4US)

August 27, 2026 updated by: Precisis US, Inc.

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10032
        • Columbia University Irving Medical Center/New York Presbyterian Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Diagnostic of non-epileptic seizures
  • Active idiopathic generalized epilepsy
  • Recent status epileptics (<12 months)
  • Clinically significant or unstable medical condition
  • Active psychosis, major depression, suicidal ideation (<6 months)
  • Pregnancy
  • Implanted with brain stimulation device or active Vagus Nerve Stimulation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.
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.
Sham Comparator: Control group
Participants in the Control group have stimulation parameters turned off. Participants do not feel if they are stimulated or not.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage reduction in the monthly seizure rate [Effectiveness]
Time Frame: Baseline and months 5 and 6
Percentage reduction in the monthly seizure rate during months 5 and 6 post-randomization compared to 3 months pre-implant baseline in the Intervention group versus the Control group.
Baseline and months 5 and 6
Incidence of Serious Adverse Events [Safety and Tolerability]
Time Frame: From implant to days 28 and 84 post-implant
  • Acute Serious Adverse Event incidence in the study population
  • Short term chronic Serious Adverse Event incidence in the study population
From implant to days 28 and 84 post-implant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Seizure Frequency Responder Rate
Time Frame: from Baseline to 6 months
Comparison between study arms of the proportion of patients who reach at least 50 % of monthly seizure frequency reduction between the baseline and the follow-up months 5 and 6
from Baseline to 6 months
Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]
Time Frame: Baseline to 6 months
Comparison of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between the study arms. BDI-II scores from 0 (no or minimal depression) to 63 (severe depression).
Baseline to 6 months
Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]
Time Frame: Baseline to 6 months
Evaluation of Beck Depression Inventory (BDI-II) changes form baseline to follow-up month 6 between in the Intervention group. BDI-II scores between 0 (no or minimal depression) to 63 (severe depression).
Baseline to 6 months
Quarterly Seizure Frequency Evaluation
Time Frame: Baseline to 18 months
Percentage change in the quarterly seizure frequency between baseline and one year after stimulation start
Baseline to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precisis US, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2026

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2030

Study Registration Dates

First Submitted

November 27, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

December 24, 2025

Study Record Updates

Last Update Posted (Actual)

August 28, 2026

Last Update Submitted That Met QC Criteria

August 27, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV08-048

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study results will be submitted for publication in peer-review journal(s) after completion of study endpoints. Research ideas can be shared with the Primary Investigators for analysis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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