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NCT06144047Recruiting

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG

Real World Testing and Cost-effectiveness Analysis of Subcutaneous EEG (REAL-ASE)
King's College LondonClinicalTrials.govdeviceDevice trial
Verified
Study focus
Disease/Condition
Epilepsy
Drug/Device/Intervention
EEG SubQ subcutaneous EEG device
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
King's College London
Location
London, United Kingdom
Timeline & enrollment
Phase
N/A
Start date
Jul 18, 2023
End date
Sep 30, 2025
Enrollment
33 participants
Primary outcome

Diagnostic accuracy of rapid data review of 24/7 EEG SubQ solution,Diagnostic accuracy of 24/7 EEG SubQ solution compared to diary,Clinician rating of accuracy of 24/7 EEG SubQ

Summary

The study will investigate whether a novel method to accurately count epileptic seizures,
 using a CE-marked minimally-invasive ultra long-term subcutaneous electroencephalography
 (EEG) solution (UNEEG™ SubQ , including 24/7 EEG SubQ), (i) is more accurate than a
 participant-reported seizure diary; (ii) is feasible and acceptable to participants and
 clinicians; (iii) reduces impacts of epilepsy and improves quality-of-life; and (iv) provides
 gains to the healthcare system when rolled-out into the National Health Service (NHS). 33
 participants with drug-resistant epilepsy will be implanted with the UNEEG™ SubQ device and
 will collect data for six months. Annotated seizures from the EEG data will be sent weekly to
 the treating clinicians, who will communicate with the participants on a monthly basis, and
 will be free to make any management changes.

ICD-10 classifications
EpilepsyEpilepsy, unspecifiedOther epilepsyStatus epilepticusOther status epilepticus
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06144047
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06144047 through Pure Global AI's free database. This phase not specified trial is sponsored by King's College London and is currently Recruiting. The study focuses on Epilepsy. Target enrollment is 33 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.