EASEE® System Pivotal Study for the United States of America

NCT07301346 | Not Yet Recruiting DMC FDA Device

• 1 other identifier: CV08-048
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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:

• 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

Keywords

EASEE System; Precisis; Neurostimulation; Epilepsy; Focal Cortex Stimulation

Outcome Measures

Primary Outcomes (2)

• Percentage reduction in the monthly seizure rate [Effectiveness]

  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]

  * 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 Outcomes (4)

• Seizure Frequency Responder Rate

  from Baseline to 6 months

• Beck Depression Inventory (BDI-II) accross Arms [Patient Reported Outcome]

  Baseline to 6 months

• Beck Depression Inventory (BDI-II) in the Intervention Group [Patient Reported Outcome]

  Baseline to 6 months

• Quarterly Seizure Frequency Evaluation

  Baseline to 18 months

Study Arms (2)

Intervention group

EXPERIMENTAL

Participants in the Intervention group receive brain neurostimulation. Participants do not feel if they are stimulated or not.

Device: Implantable minimaly invasive brain stimulator

Control group

SHAM COMPARATOR

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

Interventions

Implantable minimaly invasive brain stimulator DEVICE

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Precisis US, Inc.: lead

MeSH Terms

Conditions

Epilepsy

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Central Study Contacts

Perry Rice

CONTACT

+49 6221 6559321; p.rice@precisis.de

Aude Yulzari

CONTACT

+49 6221 6559321; a.yulzari@precisis.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2025
• First Posted: December 24, 2025
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2029
• Study Completion (Estimated): July 1, 2030
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share