Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.
Reason given: Futility analysis reached
Key facts
- Where
- Boston, Cleveland, Great Neck, Houston, Los Angeles, Neptune City, Philadelphia, Rochester, and Tampa, United StatesSee the 9 sites
Where in United States
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Cleveland Clinic, Neurological InstituteCleveland, United StatesNo longer taking part
- Northwell Health Department of NeurosurgeryGreat Neck, United StatesNo longer taking part
- UT Health HoustonHouston, United StatesNo longer taking part
- University of CaliforniaLos Angeles, United StatesNo longer taking part
- Hackensack Meridian HealthNeptune City, United StatesNo longer taking part
- University of PennsylveniaPhiladelphia, United StatesNo longer taking part
- Mayo ClinicRochester, United StatesNo longer taking part
- University of South Florida (USF) Neurology DepartmentTampa, United StatesNo longer taking part
Trial details
- Who runs it
- UNEEG Medical A/S
- Trial code
- NCT04526418
- Record updated
- 5 September 2025
- Original description
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.Read full original descriptionShow less
Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region. An Open-label, Prospective, Paired, Comparative Study.
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
Inclusion: 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: 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 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); 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; Infection at the implant site; Subject has abnormal Laboratory findings as follows:; Serum creatinine ≥ 3 times upper reference value; Alanine aminotransferase (ALT), alkaline phosphatase or bilirubin ≥ 3 times upper reference value; Activated Partial Thromboplastin Time (APTT) \> 50 seconds; thrombocyte count \< 50 or \>1000 x 109/L; International Normalised Ratio (INR) ≥ 1.6; Any other clinical or paraclinical finding that in the opinion of the Investigator would interfere with participation in the study or would confound interpretation of the study results; Subject has skeletal deformities or damage at the proposed implantation site to an extent that impedes correct electrode placement; Subject is pregnant; Subject has contraindicated profession or hobby; Subject is scheduled to undergo contraindicated treatments/investigations; Subject has contraindication to the use of anesthetic used for in/ex plantation; Subject is unable to use/operate the device system.