Feasibility Performance Study of ABL90 FLEX PLUS HEM

Recruiting now

Conditions studied: Hemolysis

In brief

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.

Key facts

Study ID

NCT07345091

Run by

Radiometer Medical ApS

People needed

95

Starts

2025-08-04

Expected to finish

2026-06-10

Last updated by the study team

2026-01-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

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• Subject with an invalid written informed consent or who has withdrawn consent.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

Where it is running

• Bispebjerg Hospital — Copenhagen, NV, Denmark (enrolling)

Full record on ClinicalTrials.gov

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