Ignite Creation Date:
2024-05-06 @ 7:24 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06002971
Status:
RECRUITING
Last Update Posted:
2023-10-26
First Post:
2023-08-08
Brief Title:
CONNEQT Pulse Validation Study
Sponsor:
Mount Carmel Health System
Organization:
Mount Carmel Health System
Study Overview
Official Title:
Validation of the CONNEQT Blood Pressure Monitoring System in a Pregnant Patient Population
Status:
RECRUITING
Status Verified Date:
2023-10
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:
The purpose of this study is to validate the accuracy of the CONNEQT Pulse blood pressure monitoring system for the measurement of blood pressure as compared to a gold standard auscultatory sphygmomanometer in a pregnant population
Detailed Description:
Clinical staff will review patients medical record to determine eligibility Following informed consent a brief medical history will be collected Serial blood pressure measurements will be collected to compare an auscultatory sphygmomanometer to blood pressure measurements of the CONNEQT Pulse blood pressure monitoring system in a pregnant population according to ISO protocol 81060-2
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None