MedTrace Logo

Comparison Of NeuroNaute Smart System to a Standard EleCTroencephalogram System in Hospital

NCT03379272 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-11-11

No results posted yet for this study

Summary

The proposed study is designed to evaluate the performance of the Neuronaute in comparison with the gold standard EEG in patients with a regular appointment at the hospital. The design of this study is guided by two overriding factors : (i) epileptics disorders suspected or either (ii) epileptics already diagnosed.

Volunteers will be asked to participate to this study. This study will enroll 35 outpatient subjects aged 18 to 85. Informed consent will be obtained from the patients, and assent from the subjects, prior to any form of assessment or intervention as part of the study.

Patients will be submitted to the studied device record Neuronaute following by the gold standard EEG.

A grid with all EEG activity recorded during the trial will be provided for evaluation after completion of the trial.

Conditions

Interventions

DEVICE

GOLDSTANDARD

RECORDING WITH EEG GOLDSTANDARD

DEVICE

NEURONAUTE

RECORDING WITH NEURONAUTE

Sponsors & Collaborators

  • Pitié-Salpêtrière Hospital

    collaborator OTHER

  • BioSerenity

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-20
Primary Completion
2020-12-20
Completion
2020-12-20

More Related Trials

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 NCT03379272 on ClinicalTrials.gov