Feasibility Performance Study of ABL90 FLEX PLUS HEM
Feasibility Performance Study Protocol for ABL90 FLEX PLUS HEM
Radiometer Medical ApS
95 participants
Aug 4, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- Subject must be 18 years of age or older
- Informed consent is obtained:
- Directly from the subject, if they are competent and able to understand the provided information and voluntarily agree to participate, or
- If the subject is temporarily incapacitated and unable to provide informed consent at the time of sample collection, written informed consent will be obtained from the subject's legally designated representative (LDR). when the subject regains capacity after enrollment, they will be informed of study inclusion and given the opportunity to withdraw consent.
- Subject evaluated as suitable according to the protocol and for the study by the principal investigator or designee.
Exclusion Criteria3
- Subject where sample collection is evaluated by PI or designee to impose unnecessary risk.
- Subject with an invalid written informed consent or who has withdrawn consent.
- Subject with known pregnancy or who is breastfeeding.
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Interventions
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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07345091