NCT06078943

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 612 (estimated)
• Sponsor: Radiometer Medical ApS · Industry
• Sex: All
• Age: 1 Day – 28 Days
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Congenital Heart Disease

Interventions

Type	Name	Description
DEVICE	method comparison	to quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 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)

Timeline

• Start date: 2023-03-17
• Primary completion: 2024-01-13
• Completion: 2024-01-30
• First posted: 2023-10-12
• Last updated: 2023-10-12

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study