Assessing the accuracy of the Withings BPM Pro 2 blood pressure device
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.
This study is testing how accurately the Withings BPM Pro 2 blood pressure device measures blood pressure in everyday people to make sure it gives reliable readings.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Withings Industry-sponsored |
| Locations | 1 site (Yerevan) |
| Trial ID | NCT06957847 on ClinicalTrials.gov |
What this trial studies
This study evaluates the accuracy of the Withings BPM Pro 2, an automatic oscillometric blood pressure measuring device, in measuring blood pressure at the brachial level. It involves participants from the general population who meet specific eligibility criteria, including age and arm circumference. The study aims to validate the device's performance in a real-world setting, ensuring it provides reliable blood pressure readings.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with an arm circumference between 22 cm and 42 cm.
Not a fit: Patients with arrhythmias, poor quality of Korotkov sounds, or those with certain medical devices or skin conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved accuracy in blood pressure monitoring, benefiting patients with hypertension.
How similar studies have performed: Other studies have shown success in validating blood pressure measuring devices, indicating that this approach is not entirely novel but still important.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Yerevan
- N2 — Yerevan, Armenia (Recruiting)
Study contacts
- Study coordinator: Ruiyi Yang, PhD
- Email: clinical-trials@withings.com
- Phone: +33 1.41.46.04.60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.