Skip to main content
OpenTrials
Completed

NCT Number: NCT06957847

Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP)

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 the general population

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

N2

Yerevan, 0002, Armenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient older than 18 years;
  • Patient who signed the informed consent form;
  • Patient followed-up at site (in-patient or out-patient);
  • Patient with arm circumference between 22 cm and 42 cm.

Exclusion criteria

  • Patient unable to give a consent or understand properly protocol information;
  • Patient suffering from arrhythmia;
  • Patient with poor quality of Korotkov sounds;
  • Patient for whom K5 sounds are absent;
  • Patient wearing an implantable electric medical device (pacemaker,…);
  • Patient with both upper arms suffering from open wound and/or damaged skin.

Treatment and study plan

Blood Pressure Measurement

Device

The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)

Primary outcomes

  1. Blood pressure measurement performance evaluation per measure

    Time frame: The time frame is three months.

    The blood pressure (systolic and diastolic blood pressure) measurement performance will be established using the mean value of the differences and the standard deviation between the device under study and the reference for each measure.

  2. Blood pressure measurement performance evaluation by subject

    Time frame: The time frame is three months.

    The blood pressure measurement performance by subject will be established using the mean value of the differences and the standard deviation between the averaged per subject value of blood pressure (systolic and diastolic blood pressure) device under study and its reference.

Secondary outcomes

  1. Safety use of the device

    Time frame: The time frame is three months.

    The rate of adverse effects.

Sponsors and collaborators

Lead sponsor

Withings

Industry

Registry information

Official study 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 The General Population.

Acronym: WIHYP-GP

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 5, 2025
Registry last updated
Feb 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.