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New blood pressure cuff aims to replace needles for tiny patients

NCT ID NCT07684885

Knowledge-focused Sponsor: GE Healthcare Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests a new non-invasive blood pressure (NIBP) device in newborns and children up to 18 years old. The device uses a cuff on the arm or thigh to measure blood pressure without needles. Researchers compare these readings to standard invasive measurements to see how accurate the new method is. If it works well, it could offer a safer, less painful way to monitor blood pressure in young patients.

What this could mean

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

What this could lead to
If successful, this could lead to a more accurate, cuff-based blood pressure monitor for infants and children, reducing the need for invasive lines.
What could go wrong
This is an early-stage accuracy study, not a treatment trial. The device may not perform as well as expected across all ages and sizes.

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

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

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

Up to 18 years

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: * Age requirement: 0 to \< 18 years. * For children under 15 years old: Has a guardian or other legal representative who is able to provide consent of a guardian OR * For children between the age of 15-17 years; able to provide written consent form and the legal guardians can be reached to be informed of the study participation. * Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 3 cm to 33 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm). * Have an arterial line as a standard of care, which measures invasive blood pressure. * Expected to remain in the unit for the duration of the study procedure. Exclusion Criteria: * Have previously participated in this study (no subject may participate more than once). * Subjects with peripheral arterial diseases (causing left/right arm difference). * Hemodynamically unstable subjects Subjects with complications on vasoactive agents at discretion of the Investigator. * Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning. * Are suffering from infection(s) or immunocompromised subjects that require isolation. * For adolescents of child-bearing potential, who are currently pregnant, suspected to be pregnant, or are currently lactating. * PI, designee or caring physician decision due to subject health conditions

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Conditions

The condition(s) this trial relates to.

hypertensive disorder

As listed by the trial registrant

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

Blood pressure Blood pressure measurement

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Helsinki University Hospital

    RECRUITING

    Helsinki, 00290, Finland

  • Helsinki University Hospital

    RECRUITING

    Helsinki, 00290, Finland

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