Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy In… (NCT04526418) | Clinical Trial Compass
TerminatedNot Applicable
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
Stopped: Futility analysis reached
United States64 participantsStarted 2021-04-21
Plain-language summary
The 24/7 EEGâ„¢ 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
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. Subject is 18-75 years old.
✓. Semiology of seizures compatible with temporal lobe involvement.
✓. Paraclinical findings supporting temporal seizure involvement. Such proof may consist of: - previous EEG recording interpreted as compatible with temporal involvement OR - radiological findings demonstrating pathology in the temporal area (CT, MRI, FDG-PET or SPECT).
✓. Uncontrolled epileptic seizures.
✓. Subject has planned clinical EMU admission with an admission goal including capturing epileptic seizures, within 12 weeks after the date of UNEEG™ SubQ implant.
✓. Subject is willing and able to provide written informed consent.
✓. Subject is able to complete all study-required procedures, assessments and follow-up.
Exclusion criteria
✕. Subject has a condition that places him/her at a high at high risk of surgical complications, such as an active systemic infection or a hemorrhagic disease.
What they're measuring
1
number of seizures
Timeframe: comparasion in EMU for 3-14 days period, where patients are hospitalized.
. Subject receives frequent (more than 2 days per week) treatment with drugs of the following types:
✕. antiplatelets
✕. anticoagulants
✕. chemotherapeutics
✕. non-steroid anti-inflammatory drugs (NSAID)
✕. Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement.
✕. Subject is involved in therapies with other active implantable devices that deliver electrical energy above the clavicular area, such as implantable brain stimulation, external/transcranial brain stimulation, vagus nerve stimulator (VNS) and cochlear implant(s).