Data Collection for Validation of an NIBP Algorithm in Pregnant Women

Status Recruiting

Clinical Trial Summary

The purpose of the study is to collect per subject blood pressure data on the device's intended population as described in the International Organization for Standardization (ISO) Standard 81060-2:2018+A1:2020 Non-invasive sphygmomanometers.

Clinical Trial Description

The purpose of the study is to collect data per subject NIBP measurements by (1) oscillometric means using the GE NIBP Auscultatory Algorithm and (2) by conventional auscultatory means in a pregnant population. These measurements include Systolic BP (mmHg) and Diastolic BP (mmHg). The secondary objective of this study is to collect per procedure and log files from the device. The safety objective of this study is to collect safety information, including type and number of adverse events, serious adverse events and device issues. This is an open label, single-site, single arm, prospective, pivotal study including a training phase and a validation phase with demographics-based stratification quota. Subjects are sequentially tested with investigational and reference blood pressure measurements. ;

Study Design

Related Conditions & MeSH terms

Blood Pressure

Clinical Trial Details

NCT number	NCT05789849
Study type	Interventional
Source	GE Healthcare
Contact	GEHC Patient Care Solutions Research Program Integrator
Phone	+1-262-290-6037
Email	meghan.terry@ge.com
Status	Recruiting
Phase	N/A
Start date	September 14, 2022
Completion date	September 2023

View Details

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