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

Withings

Status: Enrolling

Conditions: Hypertension

Treatments: Device: Blood pressure measurement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06957847

2025-A00050-49

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

120 participants in 1 patient group

All patients

Experimental group

Description:

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

Treatment:

Device: Blood pressure measurement