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Early Feasibility Study on Epios Leads

NCT04796597 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2023-11-14

No results posted yet for this study

Summary

The Epios early feasibility study aims to explore the uses of novel sub-scalp lead devices in the detection of epileptic seizures. Epios leads are inserted subcutaneously through dedicated tunneling toolkits and have been designed for continuous EEG recording in inpatients.

This clinical investigation is part of a stepwise program to validate the entire Epios system and it starts with the validation of the Epios leads alone in this two steps study.

Conditions

Interventions

DEVICE

Subcutaneous implantation of Epios sub-scalp leads

The sub-scalp Epios Leads will be implanted by a trained neurosurgeon and will provide epicranial EEG recording of specific cortical areas identified by the neurologist.

Sponsors & Collaborators

  • Wyss Center for Bio and Neuroengineering

    lead OTHER

Principal Investigators

  • Maxime Baud, MD, PhD · Universitätklinik für Neurologie, Inselspital, Bern University Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-23
Primary Completion
2023-07-07
Completion
2023-11-02

Countries

  • Switzerland

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04796597 on ClinicalTrials.gov