The 24/7 EEG™ SubQ system will be compared to simultaneously recorded video-EEG in the Epilepsy Monitoring Unit (gold standard) and to self-reported seizure log books throughout 12 weeks of outpatient EEG recording. The present study is a 12-week open-label, prospective study with a paired, comparative design for pivotal evaluation of the safety and effectiveness of the 24/7 EEGTM SubQ system in subjects with epilepsy involving the temporal lobe region . 2-5 sites in Europe Up to 10 sites in US
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
64
Electrographic seizure recording sensitivity of an ipsilaterally implanted 24/7 EEG™ SubQ system: proportion of identified ipsilateral seizures as compared to ipsilateral video-EEG during admission to the Epilepsy Monitoring Unit
University of California
Los Angeles, California, United States
University of South Florida (USF) Neurology Department
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
number of seizures
numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
Time frame: comparasion in EMU for 3-14 days period, where patients are hospitalized.
adverse event
safety reporting
Time frame: 2 years
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Mayo Clinic
Rochester, Minnesota, United States
Hackensack Meridian Health
Neptune City, New Jersey, United States
Northwell Health Department of Neurosurgery
Great Neck, New York, United States
Cleveland Clinic, Neurological Institute
Cleveland, Ohio, United States
University of Pennsylvenia
Philadelphia, Pennsylvania, United States
UT Health Houston
Houston, Texas, United States
Hopital Erasme - Universite Libre de Bruxelles
Brussels, Belgium
...and 2 more locations