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

February 17, 2026 updated by: Withings

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.

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

89

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Armenia
      • Yerevan, Armenia, 0002
        • N2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: All patients
Patients consenting to participate to the study and compliant to the inclusion criteria
Device: Blood pressure measurement
The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
The time frame is three months.
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.
The time frame is three months.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Withings

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2025

Primary Completion (Actual)

August 21, 2025

Study Completion (Actual)

November 18, 2025

Study Registration Dates

First Submitted

May 2, 2025

First Submitted That Met QC Criteria

May 2, 2025

First Posted (Actual)

May 5, 2025

Study Record Updates

Last Update Posted (Actual)

February 18, 2026

Last Update Submitted That Met QC Criteria

February 17, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2025-A00050-49

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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