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Blood pressure algorithm study ends early – no major breakthrough

NCT ID NCT05654714

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested two new algorithms (SureBP and StepBP) in a blood pressure device to see if they measure blood pressure accurately in adults and children ages 3 and up. The goal was to check if the device meets international accuracy standards. The study was terminated early, so results are limited.

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.

Participants

152 people

The number who actually took part.

Started

Mar 2023

Finished

Nov 2023

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

3 years and older

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Subjects must be able to provide an informed consent or have legally authorized representative consent to participate. * Subject must be willing and able to comply with the study procedures. * Subject must be ≥ 3 years of age * Subjects that are between 7 and 17 years of age must provide assent to participate in the study. * Subject or legally authorized representative must be able to read, write, speak in English, French or Italian. * Subjects must have an arm circumference in the range of 12-55 cm and fit into the usable range for the reference cuffs. * Subject must be able to have blood pressures measured on the Left arm. Exclusion Criteria: * Lack of Informed consent. * Subjects with deformities or abnormalities that may prevent proper application of the device under test. * Subject is evaluated by the investigator or clinician and found to be medically unsuitable for participation in this study. * Subjects with known heart dysrhythmias. * The subject is in acute distress, i.e., severe pain or, severe emotional distress or agitation that would inhibit him/her from participating in the study. * The subject has any known contraindication to blood pressure measurement. * Subjects with compromised circulation or peripheral vascular disease. * Subjects with clotting disorders or taking prescribed blood thinners. * Subjects that cannot tolerate sitting for up to 1 hour. * Subject with a blood pressure demographic that has already been filled. * Subjects with a severe contact allergy to cuff material. * Subjects with a history of skin fragility or breakdown, such as ecchymosis or lacerations, affecting the upper extremities that would affect the application of noninvasive blood pressure cuff. * Subjects whose arm circumference does not fall within the unusable range for the reference cuffs. * Subjects with no audible K5 sound. * Subject is pregnant and/or breastfeeding.

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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

  • Baxter Investigational Site

    Bologna, 40138, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.