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Feasibility Performance Study of ABL90 FLEX PLUS HEM

NCT07345091 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 95

Last updated 2026-01-15

No results posted yet for this study

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.

Conditions

  • Hemolysis

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.

Sponsors & Collaborators

  • Bispebjerg Hospital

    collaborator OTHER

  • Radiometer Medical ApS

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2026-05-10
Completion
2026-06-10
FDA Device
Yes

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07345091 on ClinicalTrials.gov