147
Participants
Start Date
June 30, 2012
Primary Completion Date
April 30, 2014
Study Completion Date
April 30, 2014
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."
United States, North Carolina, Charlotte
United States, Illinois, Chicago
United States, Texas, Houston
United States, Texas, Houston
United States, Texas, San Antonio
United States, Texas, Austin
Lead Sponsor
Cyberonics, Inc.
INDUSTRY