A Prospective Long-Term Follow-Up Study to Evaluate the Use of the Minder Device to Aid in Treatment After Actionable Event Identification in Patients Diagnosed With Epilepsy.

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Contact Information
Primary
Epiminder, Director of Clinical Trials
clinical@epiminder.com
800-717-3185
Time Frame
Start Date: 2025-11-20
Estimated Completion Date: 2029-01
Participants
Target number of participants: 210
Treatments
Observational
Minder System
Related Therapeutic Areas
Sponsors
Leads: Epiminder America, Inc.

This content was sourced from clinicaltrials.gov