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

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.

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06957847

Acronym

WIHYP-GP

Enrollment

Registered

2025-05-05

Start date

2025-04-28

Completion date

2025-11-18

Last updated

2026-02-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief 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 the general population

Interventions

DEVICEBlood pressure measurement

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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.

Design outcomes

Primary

Measure	Time frame	Description
Blood pressure measurement performance evaluation per measure	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.
Blood pressure measurement performance evaluation by subject	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

Measure	Time frame	Description
Safety use of the device	The time frame is three months.	The rate of adverse effects.

Countries

Armenia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 19, 2026