HypertensionWIHYP-GPNCT06957847

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

A study testing Blood pressure measurement in people with Hypertension, run by Withings at 1 site in Armenia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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 the general population Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Hypertension
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: 89 participants
Where: 1 siteArmenia
Study dates: 28 Apr 2025to 18 Nov 2025
Phase: Interventional
Are there results?: None posted in the registry

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;
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.

Armenia1 site

N2
Yerevan, 0002

Other trials in Armenia

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 The General Population.

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

Conditions: Hypertension
Being tested: Blood pressure measurement
Medical subject headings: Hypertension

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 groups in NCT06957847
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 performance 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: The time frame is three months.
Blood pressure measurement performance evaluation by subject
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.
Measured: The time frame is three months.

Secondary outcomes (1)

Safety use of the device
The rate of adverse effects.
Measured: The time frame is three months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Apr 202518 Nov 2025

First posted5 May 2025
Study start28 Apr 2025
Primary completion21 Aug 2025
Study completion18 Nov 2025

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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06957847
Sponsor's protocol ID: 2025-A00050-49
Acronym: WIHYP-GP
Status last verified: Feb 2026
First submitted: 2 May 2025
Last updated: 18 Feb 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Feb 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 The General Population.
ClinicalTrials.gov ID: NCT06957847
Acronym / sponsor ID: WIHYP-GP / 2025-A00050-49
Conditions: Hypertension
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: WithingsIndustry (pharma, biotech, devices)
Study start: 28 Apr 2025 (actual)
Primary completion: 21 Aug 2025 (actual)
Study completion: 18 Nov 2025 (actual)
First posted: 5 May 2025 (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 the general population

Study design

Primary purpose: Device feasibility
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 (4 listed)

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.

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 performance evaluation per measure
Time frame: 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
Time frame: 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.

1 secondary outcome

Safety use of the device
Time frame: The time frame is three months.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2026.
Individual participant dataSharing planned: No

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
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Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
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Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
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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. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

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, 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 4 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: finished, as of the sponsor's last update on 18 Feb 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood pressure measurement performance evaluation per measure (time frame: The time frame is three months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06957847.

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 18 Feb 2026.