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
Epilepsy
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
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
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University of California, Los Angeles, California, United States, 90095
University of South Florida (USF) Neurology Department, Tampa, Florida, United States, 33606
Massachusetts General Hospital, Boston, Massachusetts, United States, 02114
Mayo Clinic, Rochester, Minnesota, United States, 55905
Hackensack Meridian Health, Neptune, New Jersey, United States, 07753
Northwell Health Department of Neurosurgery, Great Neck, New York, United States, 11021
Cleveland Clinic, Neurological Institute, Cleveland, Ohio, United States, 44195
University of Pennsylvenia, Philadelphia, Pennsylvania, United States, 19104
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
For general information about clinical research, read Learn About Studies.
18 Years to 75 Years
ALL
No
UNEEG Medical A/S,
Michael Gelfand, PRINCIPAL_INVESTIGATOR, University of Pennsylvania
2026-04-30