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

NCT06957847 | Completed

• 1 other identifier: 2025-A00050-49
• Study Type: interventional
• Target: 89
• Locations: 1 country
• Sites: 1

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

Conditions

Hypertension

Outcome Measures

Primary Outcomes (2)

• Blood pressure measurement performance evaluation per measure

  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

  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 Outcomes (1)

• Safety use of the device

  The time frame is three months.

Study Arms (1)

All patients

EXPERIMENTAL

Patients consenting to participate to the study and compliant to the inclusion criteria

Device: Blood pressure measurement

Interventions

Blood pressure measurement DEVICE

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

All patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Withings: lead

Study Sites (1)

N2

Yerevan, 0002, Armenia

Location

MeSH Terms

Conditions

Hypertension

Interventions

Blood Pressure Determination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Physical Examination

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 5, 2025
• Study Start: April 28, 2025
• Primary Completion: August 21, 2025
• Study Completion: November 18, 2025
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)