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Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-eclampsia
Sponsor: Withings
Summary
The aim of the study is to assess the accuracy of the automatic oscillometric BP measuring device at the brachial level, the WITHINGS BPM Pro 2, in pregnancy and pre-eclampsia
Official title: CLINICAL VALIDATION OF THE BRACHIAL BLOOD PRESSURE MEASURING DEVICE WITHINGS BPM PRO 2 ACCORDING TO "THE UNIVERSAL PROTOCOL FOR THE VALIDATION OF BLOOD PRESSURE MEASURING DEVICES BY THE ASSOCIATION FOR THE ADVANCEMENT OF MEDICAL INSTRUMENTATION / EUROPEAN SOCIETY OF HYPERTENSION / INTERNATIONAL ORGANIZATION FOR STANDARDIZATION (AAMI/ESH/ISO) (AND ITS AMENDMENT 1 (2020) AND 2 (2024))" IN PREGNANCY AND PRE-ECLAMPSIA
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
45
Start Date
2026-05-11
Completion Date
2026-09-30
Last Updated
2026-05-19
Healthy Volunteers
Yes
Conditions
Interventions
Blood pressure measurement
The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)
Locations (1)
N2
Yerevan, Armenia, Armenia