Ignite Creation Date:
2024-05-06 @ 6:02 PM
Last Modification Date:
2024-10-26 @ 2:40 PM
Study NCT ID:
NCT05520476
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-14
First Post:
2022-08-23
Brief Title:
Neuroliten MVP System Clinical Observation Study
Sponsor:
Enliten AI
Organization:
Enliten AI
Study Overview
Official Title:
Neuroliten MVP System Clinical Observation Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an observational study for data collection from subjects diagnosed with Epilepsyintractable seizures The Neuroliten MVP System will not be used for patient management or treatment decisions
Detailed Description:
Neuroliten MVP system stores the data obtained from wearables caregivers and all audiovideo recording of seizure activity that the caregiver captures associated with a seizure episode
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of familycaregivers
The secondary objective is to identify the vital signs andor neurological indicators that are associated with seizure onset
The primary objective of this study is to obtain vital signs and neurological indicators via the Neuroliten MVP System to correlate to the onset of seizures that are detected by the observations of familycaregivers
The secondary objective is to identify the vital signs andor neurological indicators that are associated with seizure onset
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None