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Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data

NCT01626599 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 147

Last updated 2020-08-05

No results posted yet for this study

Summary

This study is designed to collect data to support development of a novel product designed to sense changes in heart rate or movement during periods of sleep in people with epilepsy. When a potential seizure is detected, the system sends out an audio-visual notification.

Conditions

Interventions

DEVICE

ProGuardian

The investigational system is composed of a sensor, patch, hub, and caregiver application. The sensor is applied externally during periods of nocturnal sleep for up to 7 nights. The investigational system: * is not implantable and no surgical procedure is required for a human subject to use the devices; * is not for use in supporting or sustaining a human life; and * is not of substantial importance in diagnosing, curing, mitigating, or treating disease, or otherwise preventing impairment of human health. * Contains skin-contacting materials made of medical grade materials (e.g. sold for use as surgical or wound care) with well-established biocompatibility testing profiles.

Sponsors & Collaborators

  • Cyberonics, Inc.

    lead INDUSTRY

Principal Investigators

  • Jason Begnaud · Cyberonics, Inc.

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

Countries

  • United States

Study Locations

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 NCT01626599 on ClinicalTrials.gov