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New blood pressure cuff aims to replace needles

NCT ID NCT07628296

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jul 09, 2026 · Updated 5 times

Summary

This study is testing a new non-invasive blood pressure device that uses a cuff and special algorithm to measure blood pressure. Researchers will compare its readings to those from an arterial line, which is the most accurate method but requires a needle in an artery. The study involves 15 adults who already have an arterial line as part of their care. The goal is to see if the cuff device can match the accuracy of the invasive method.

What this could mean

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

Active substance
NIBP Standard Parameter Module with SuperSTAT algorithm (device)
What this could lead to
If successful, this could lead to more accurate non-invasive blood pressure monitoring, reducing the need for invasive arterial lines.
What could go wrong
This is a very small early-stage study (15 participants) focused on data collection, not treatment. The device may not prove accurate enough for widespread use.

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 130 people

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

Started

May 2026

Expected to finish

Jun 2027

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

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: 1. Age requirement: 18 and over. 2. Have an upper limb (right OR left side) that fits the cuff size of the device (circumference ranging 17 cm to 40 cm) OR have a thigh (right OR left side) that fits a cuff size of the device (circumference ranging 38 to 50 cm). 3. Have an arterial line as a standard of care, which measures blood pressure at the aortic root. 4. Able to provide written informed consent. 5. Expected to remain in the unit for the duration of the study procedure. Exclusion Criteria: 1. Have previously participated in this study (no subject may participate more than once). 2. Pregnant and lactating women per site standard of care. 3. Subjects with peripheral arterial diseases (causing left/right arm difference) 4. Hemodynamically unstable subjects at the discretion of the investigator. 5. Exhibited injuries, deformities, intravenous lines, or other abnormalities that, in the opinion of the Investigator, may prevent proper cuff application or functioning. 6. Are suffering from infection(s) or immunocompromised patients that require isolation. 7. PI or designee 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

    1 site. 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

  • Tampere Heart Hospital

    RECRUITING

    Tampere, Finland

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