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New blood analyzer feature aims to catch sample damage

NCT ID NCT07345091

Diagnosis Sponsor: Radiometer Medical ApS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new hemolysis detection feature on the ABL90 FLEX PLUS HEM blood gas analyzer. Hemolysis (damage to red blood cells) can skew test results. Researchers will collect blood samples from 95 adults and check if the device correctly flags damaged samples. The goal is to improve the reliability of blood test results.

What this could mean

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

Active substance
ABL90 FLEX PLUS HEM device (blood gas analyzer with hemolysis detection feature)
What this could lead to
If successful, this could make blood test results more reliable by automatically flagging damaged samples.
What could go wrong
This is a small feasibility study (95 participants) testing a device feature, not a treatment. It may not prove the feature works in all real-world settings.

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

About 95 people

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

Started

Aug 2025

Expected to finish

Jun 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.

Who is studied

Adults, 18 years of age or older, that have been admitted to the hospital and undergo blood collection as part of their standard care.

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: * Subject must be 18 years of age or older * Informed consent is obtained: * Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or * If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent. * Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee. Exclusion Criteria: * Subject where sample collection is evaluated by PI or designee to impose unnecessary risk. * Subject with an invalid written informed consent or who has withdrawn consent. * Subject with known pregnancy or who is breastfeeding.

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Conditions

The condition(s) this trial relates to.

Hemolysis

As listed by the trial registrant

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

Hemolysis

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

  • Bispebjerg Hospital

    RECRUITING

    Copenhagen, NV, 2400, Denmark

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