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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-28

Study Completion Date

2025-09-30

Brief Summary

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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

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Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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All patients

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

Group Type EXPERIMENTAL

Blood pressure measurement

Intervention Type DEVICE

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

Interventions

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Blood pressure measurement

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes