Withings Hypertension Notification Retrospective Study (NCT07631715) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Withings Hypertension Notification Retrospective Study
France2,500 participantsStarted 2026-03-01
Plain-language summary
This retrospective, non-interventional clinical investigation evaluates the diagnostic performance of the Withings Hypertension Notification Feature (HTNF), a software-only medical device (SaMD) that analyzes demographic, anthropometric, and physiological parameters collected by Withings connected smart scales to identify patterns suggestive of hypertension. Ground-truth blood pressure measurements are obtained concurrently from Withings connected blood pressure monitors. The study tests whether the Withings HTNF achieves diagnostic performance substantially equivalent to the FDA-authorized predicate device (Apple Watch HTNF, K250507) for the purpose of 510(k) clearance.
Who can participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Users of commercially purchased, consumer-grade Withings smart scales (models Body Cardio, Body Comp, Body Scan) in a standard home environment
* Concurrent ground-truth blood pressure data collected via Withings connected blood pressure monitors (BPM, BPM+, BPM Connect, or BPM Core)
* At least 7 blood pressure measurements within a given week to establish reliable weekly hypertension status classification
* Age \>= 18 years (all regions) or \>= 22 years (United States), consistent with the predicate device age requirement
* Receipt of the study information letter without exercising the right to opt out (for applicable regulatory jurisdictions)
Exclusion Criteria:
* Users lacking valid weekly average systolic and diastolic blood pressure measurements (missing ground truth)
* Users with physiological measurements falling outside plausible clinical ranges (BMI \< 10 or \> 100 kg/m2, age \< 18/22 or \> 100 years)
* Users who exercised their right to opt out of the retrospective study
* Users without an individual Withings account (shared accounts are excluded to prevent data contamination)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Stage-Adjusted Sensitivity (Se) of the Withings HTNF Algorithm
Timeframe: up to 7 years
2
Stage-Adjusted Specificity (Sp) of the Withings HTNF Algorithm