HypertensionWIHYP-PWNCT07595016
Clinical Validation of the Blood Pressure Measuring Device Withings BPM Pro 2 in Pregnancy and Pre-Eclampsia
A study testing Blood pressure measurement in people with Hypertension and Pre-eclampsia, run by Withings at 1 site in Armenia.
Trial 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 pregnancy and pre-eclampsia Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Pre-eclampsia
- What is being tested?
- Blood pressure measurement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteArmenia
- Study dates
- 11 May 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient older than 18 years;
- Known pregnancy, in second or third trimester of pregnancy ( > 3 months);
- Patient normotensive, hypertensive or in preeclampsia;
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Armenia1 site, 1 recruiting
- Recruiting
N2
Yerevan, Armenia, 0002
Parounak ZELVEIAN, Professor, 374-10-530572, zelveian@hotmail.com
About this study
Official title: 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 Pregnancy And Pre-Eclampsia
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 pregnancy and pre-eclampsia
- Conditions
- Hypertension, Pre-eclampsia
- Being tested
- Blood pressure measurement
- Keywords
- hypertension, blood pressure monitor, pregnancy, pre-eclampsia, validation
- Medical subject headings
- Hypertension, Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood pressure measurementDevice
The patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times)
| Study group | Role | What they receive |
|---|---|---|
| All patients | Experimental | Patients consenting to participate to the study and compliant to the inclusion criteria Receives: Device: Blood pressure measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure measurement performace evaluation per measure
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.
Measured: 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start11 May 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Withings
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07595016
- Sponsor's protocol ID
- 2026-A00642-49
- Acronym
- WIHYP-PW
- Status last verified
- Jun 2026
- First submitted
- 12 May 2026
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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 Pregnancy And Pre-Eclampsia
- ClinicalTrials.gov ID
- NCT07595016
- Acronym / sponsor ID
- WIHYP-PW / 2026-A00642-49
- Conditions
- Hypertension, Pre-eclampsia
- Keywords
- hypertension, blood pressure monitor, pregnancy, pre-eclampsia, validation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- WithingsIndustry (pharma, biotech, devices)
- Study start
- 11 May 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 pregnancy and pre-eclampsia
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All patients | Experimental | Device: Blood pressure measurementPatients consenting to participate to the study and compliant to the inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient older than 18 years;
- Known pregnancy, in second or third trimester of pregnancy ( > 3 months);
- Patient normotensive, hypertensive or in preeclampsia;
- Patient who signed the informed consent form;
- Patient followed-up at site (in-patient or out-patient);
Key exclusion criteria (6 listed)
- 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,…);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood pressure measurementThe patient will be measured alternatively with a reference mercury sphygmomanometer (four times) and the device under study (3 times) | Device | All patients |
Primary outcome
Blood pressure measurement performace evaluation per measure
Time frame: 5 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood pressure measurement in people with Hypertension and Pre-eclampsia, run by Withings at 1 site in Armenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Armenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inès Bedouda (0141460460, clinical-trials@withings.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure measurement performace evaluation per measure (time frame: 5 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.