Ignite Creation Date:
2025-12-18 @ 9:20 AM
Ignite Modification Date:
2025-12-23 @ 11:09 PM
Study NCT ID:
NCT05602740
Status:
None
Last Update Posted:
2023-07-28 00:00:00
First Post:
2022-10-27 00:00:00
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Detection of hEad Pulse for Ischemic StrOke Verification Study
Sponsor:
None
Organization:
Study Overview
Official Title:
EPISODE-VS: hEad Pulse for Ischemic StrOke Verification Study
Status:
None
Status Verified Date:
2023-06
Last Known Status:
ENROLLING_BY_INVITATION
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:
EPISODE_VS
Brief Summary:
Patients suspected of stroke by a prehospital provider will have a headset placed to record their headpulse during the encounter. These measurements will be used to assess the accuracy of the device at predicting the presence of large vessel occlusion (LVO) stroke. The MindRhythm, Inc., Harmony® 5000 device is intended to be used in the pre-hospital setting by medical professionals to diagnose large vessel occlusion stroke in adults suspected of having a stroke.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: