Ignite Creation Date:
2024-05-06 @ 4:00 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04835857
Status:
RECRUITING
Last Update Posted:
2023-09-21
First Post:
2021-04-05
Brief Title:
Comparison of Cuff-Less Wrist Wearable Blood Pressure Device to Cuff Based Blood Pressure Measuring Devices
Sponsor:
Dynocardia Inc
Organization:
Dynocardia Inc
Study Overview
Official Title:
Comparison of Cuff-Less Wrist Wearable to Cuff Based Commercial Available Blood Pressure Measuring Devices in Health Volunteers With Normal or High Blood Pressure
Status:
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:
1 To compare cuff-less wrist wearable radial artery blood pressure measurements utilizing ViTrackdeveloped by Dynocardia to the cuff based commercially available blood pressure device in healthy volunteers with normal or high blood pressure
Detailed Description:
1 The ViTrack is strapped over the radial artery at the wrist The ViTrack blood pressure cuff will be utilized to obtain blood pressureBP readings in the volunteers with normal or high blood pressure The readings from the ViTrack will be compared with the readings of a cuff-based commercially available BP measuring device placed on the same arm
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?:
True
Is an FDA AA801 Violation?:
None