Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
- Conditions
- Epilepsy
- Registration Number
- NCT04526418
- Lead Sponsor
- UNEEG Medical A/S
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 64
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method number of seizures comparasion in EMU for 3-14 days period, where patients are hospitalized. numbers of seizures as detected in EEG data from SubQ to be compared with number of seizures detected in golden standard (video EEG).
- Secondary Outcome Measures
Name Time Method adverse event 2 years safety reporting
Trial Locations
- Locations (12)
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
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
Scroll for more (2 remaining)University of California🇺🇸Los Angeles, California, United States