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EpiWatch: Evaluation of a Non-EEG Physiological Signal Based Seizure Monitoring System

NCT05059002 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 242

Last updated 2025-02-04

No results posted yet for this study

Summary

To demonstrate the safety and effectiveness of the EpiWatch device in identifying tonic-clonic (TC) seizures, notifying a third-party of TC seizure occurrence, and collecting non-EEG physiological data for subsequent review during patient hospitalization in an epilepsy monitoring unit (EMU).

Conditions

  • Epilepsy, Tonic-Clonic

Interventions

DEVICE

Physiological signal monitoring and seizure detection

Data collection and as an adjunct to other methods of seizure monitoring

Sponsors & Collaborators

  • EpiWatch, Inc.

    lead INDUSTRY

Principal Investigators

  • Gregory L Krauss, MD · Johns Hopkins University

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-20
Primary Completion
2023-10-31
Completion
2023-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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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 NCT05059002 on ClinicalTrials.gov