ABL90 Flex Plus Method Comparison Study_Adults

Completed · Not applicable

Conditions studied: Diagnostic Test

In brief

The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in heparinized whole blood in a Point of Care (POC) setting.

Key facts

Study ID

NCT06078956

Run by

Radiometer Medical ApS

People needed

754

Starts

2023-07-08

Expected to finish

2025-01-31

Last updated by the study team

2025-06-27

Who can join

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

You may qualify if…

• The subject must be 18 years or older.
• Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.
• The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick.
• Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.

You may not qualify if…

• Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
• Subject, who is pregnant or breastfeeding.
• Subject, who has an invalid written informed consent or has withdrawn consent.
• Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode
• Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference.
• Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).

Where it is running

• UC Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.