ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Status Recruiting

Clinical Trial Summary

The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.

Clinical Trial Description

The main question it aims to answer is: To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT06078943
Study type	Interventional
Source	Radiometer Medical ApS
Contact	Lone Pedersen, PhD
Phone	+4528989640
Email	lone.graasboljuulpedersen@radiometer.dk
Status	Recruiting
Phase	N/A
Start date	March 17, 2023
Completion date	January 30, 2024

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