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Feasibility Performance Study of ABL90 FLEX PLUS HEM
Sponsor: 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.
Official title: Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
95
Start Date
2025-08-04
Completion Date
2026-06-10
Last Updated
2026-01-15
Healthy Volunteers
No
Conditions
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
The hemolysis detection function is a newly developed sample quality feature on the ABL90 FLEX PLUS HEM intended to detect hemolyzed samples and to improve the reliability of the results provided by blood gas analyzer.
Locations (1)
Bispebjerg Hospital
Copenhagen, NV, Denmark