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Feasibility Performance Study of ABL90 FLEX PLUS HEM | Clinical Trials | Clareo Health

RECRUITING

Feasibility Performance Study of ABL90 FLEX PLUS HEM

Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM

NCT07345091•Radiometer Medical ApS

Summary

This feasibility performance study evaluates the ABL90 FLEX PLUS HEM device for its analytical performance in a clinical setting. The study aims to evaluate the performance of the hemolysis detection feature.

Detailed Description

The study is designed to assess the feasibility and performance of the ABL90 FLEX PLUS HEM device in a clinical environment. It will involve testing whole blood samples using the device and comparing results against established reference method. The primary focus is on validating the device's performance of the hemolysis detection function. The study will be conducted at one selected clinical site with trained personnel and will follow a predefined protocol to ensure consistency and reliability of data collection. The outcomes will inform future clinical studies aimed at supporting regulatory submissions and clinical adoption.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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•Subject with an invalid written informed consent or who has withdrawn consent.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.

Locations (1)

Bispebjerg Hospital

Copenhagen, NV, Denmark

Key Dates

Start Date

August 4, 2025

Primary Completion Date

May 10, 2026

Completion Date

June 10, 2026

Last Updated

January 15, 2026

Enrollment

ESTIMATED participants

Conditions

Hemolysis

Interventions

The purpose of this study is to investigate the performance of the hemolysis detection function on the ABL90 FLEX PLUS HEM using arterial or venous whole blood

DIAGNOSTIC_TEST

Contacts

Vadim Fedulov

CONTACT

+4526311594 vadim.fedulov@radiometer.dk

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 15, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Feasibility Performance Study of ABL90 FLEX PLUS HEM

Inclusion Criteria

Exclusion Criteria

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