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RECRUITING
NCT07345091

Feasibility Performance Study of ABL90 FLEX PLUS HEM

Sponsor: Radiometer Medical ApS

View on ClinicalTrials.gov

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

DIAGNOSTIC_TEST

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