NCT04526418

Evaluation of the 24/7 EEG SubQ System for Ultra Long-Term Recording of Patients With Epilepsy Involving the Temporal Lobe Region.

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.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: UNEEG Medical A/S · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Epilepsy

Interventions

Type	Name	Description
DEVICE	24/7 EEG™ SubQ system	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

Timeline

• Start date: 2021-04-21
• Primary completion: 2025-07-22
• Completion: 2025-08-29
• First posted: 2020-08-25
• Last updated: 2025-09-05

Locations

12 sites across 3 countries: United States, Belgium, Germany

Regulatory

• FDA-regulated device study