Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 (WIHYP-GP)
Not Applicable
Recruiting
- Conditions
- Hypertension
- Registration Number
- NCT06957847
- Lead Sponsor
- Withings
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Safety use of the device The time frame is three months. The rate of adverse effects.
Trial Locations
- Locations (1)
N2
🇦🇲Yerevan, Armenia