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No more cuff? new patch could track blood pressure all day

NCT ID NCT07240831

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 9 times

Summary

This study is testing a chest-patch that uses light to measure blood pressure without a traditional arm cuff. Researchers will compare its readings over 24 hours to the standard cuff-based method in 600 adults with or without high blood pressure. The goal is to see if the patch is accurate, reliable, and more convenient for patients.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Biobeat Chest-Patch (PPG-based monitor)
What this could lead to
If successful, this could offer a more comfortable, cuffless way to monitor blood pressure continuously for a full day.
What could go wrong
This is an early validation study, not a treatment trial. The patch may not be as accurate as the standard cuff method, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

612 people

The number who actually took part.

Started

Dec 2025

Finished

Sep 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria * Females and Males subjects 18 years or older (from all skin tones/colors) * Scheduled for ABPM for hypertension screening, evaluation, or management * Subjects capable of using an application temporarily downloaded (for the duration of the study) on a personal smart phone device or on a device provided by the study sponsor * Subjects with Atrial fibrillation or Atrial flutter are eligible to participate if standard cuff-based ABPM monitor can capture blood pressure at initialization Exclusion Criteria * Indication for ABPM is orthostatic hypotension or Postural Orthostatic Tachycardiac Syndrome as indicated on the ABPM referral order * Any neurological, psychological, or other condition impairing the ability to provide informed consent or participate in the study * Inability to reliably access the Internet via a smart phone * Not able to perform standard cuff-based ABPM * Average absolute difference between the two arms is greater than 15 mmHg for Systolic Blood Pressure (SBP) or greater than 10 mmHg Diastolic Blood Pressure (DBP) during the initialization/calibration phase * Subjects with known allergy to adhesives or skin patches * Subjects with solid dark tattoos on the area where the PPG-based device is attached * Subjects who are unwilling to have their chest hair shaved, if needed, to install the device (the device uses adhesives and needs to be in direct contact with the skin without hair) * Subjects who are unwilling to comply with the study instructions (avoid vigorous exercise and showering for 24 hours while the device is in place)

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Cardiology, P.C.

    Birmingham, Alabama, 35211, United States

  • HaEmek Hospital

    Afula, 1834111, Israel

  • Henry Ford Health System

    Detroit, Michigan, 48202-2689, United States

  • Instituto Auxologico Italiano

    Milan, Italy

  • Maccabi Healthcare

    Tel Aviv, Israel

  • Mayo Clinic

    Scottsdale, Arizona, 85259, United States

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Sheba Medical Center

    Ramat Gan, Israel

  • The Holy Family Hospital Nazareth

    Nazareth, 1641100, Israel

  • U Health-University of Miami Health System

    Miami, Florida, 33136, United States

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