Diagnosing Epilepsy To EffeCT Change Long-Term Follow-Up (DETECT LTFU)

Epiminder America, Inc.

Status

Enrolling

Conditions

Epilepsy (Treatment Refractory)

Epilepsy

Treatments

Device: Previous receipt of the Minder System (implantable continuous electroencephalographic (EEG) monitoring (iCEM) system)

Study type

Observational

Funder types

Industry

Identifiers

NCT07110454

EM2402

Details and patient eligibility

About

The purpose of this research is to address the challenges of correctly monitoring, managing, and diagnosing epilepsy in participants whose seizures are not well captured by standard electroencephalography (EEG) tests and who cannot use or are not able to use more standard monitoring techniques. This research is being done to understand how the Minder System helps physicians make decisions about participant's epilepsy treatment after an actionable event. The Minder System was granted De Novo classification by the U.S. Food and Drug Administration (FDA) and is not investigational.

Participants that have completed the DETECT study and received the Minder System previously will consent to join this long-term follow-up observational study. The study will collect information about general wellbeing, use of healthcare services, and experience using the Minder data over time to support long-term epilepsy care.

All participants will continue to be followed by their treating physician and undergo assessments and visits every six (6) months until two (2) years after receiving the Minder device.

Enrollment

210 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participant met all inclusion criteria, was enrolled in the DETECT study, and received the Minder device
Participant completed the DETECT study by receiving an actionable event or by completing the 6-month follow-up visit
Participant continues to have the Minder device implanted
Participant must continue to meet relevant DETECT study inclusion criteria

Exclusion criteria

Participant meets any relevant DETECT study exclusion criteria including needing treatments or assessments that are not indicated with the Minder System like Magnetic Resonance Imaging (MRI)