Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06368193
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2024-04-05
Brief Title:
The Neuralert Stroke Monitor Pilot Trial
Sponsor:
Neuralert Technologies LLC
Organization:
Neuralert Technologies LLC
Study Overview
Official Title:
The Neuralert Stroke Monitor Pilot Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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 trial aims to demonstrate that the Neuralert Monitoring System will detect strokes before they would be identified by current standard of care Each patient will be monitored for up to five days depending on device connectivity or battery duration Each monitoring session will consist of wearing a Neuralert device on each arm For this pilot trial we are interested in learning about Wi-Fi connectivity successful data transmission clinical usability and tolerability
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None