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

NACompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

April 30, 2014

Study Completion Date

April 30, 2014

Conditions
Epilepsy
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."

Trial Locations (6)

28209

United States, North Carolina, Charlotte

60654

United States, Illinois, Chicago

77034

United States, Texas, Houston

77054

United States, Texas, Houston

78229

United States, Texas, San Antonio

78731

United States, Texas, Austin

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Cyberonics, Inc.

INDUSTRY

NCT01626599 - Study to Evaluate a New Device Designed to Collect Heart Activity and Body Movement Data | Biotech Hunter | Biotech Hunter