Status:
COMPLETED
ABL90 Flex Plus Method Comparison Study_Adults
Lead Sponsor:
Radiometer Medical ApS
Conditions:
Diagnostic Test
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The goal of this clinical trial is to validate performance claims for method comparison for the ABL90 FLEX PLUS for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb a...
Detailed Description
The main question it aims to answer is: To quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for...
Eligibility Criteria
Inclusion
- The subject must be 18 years or older.
- Informed consent collected from subject or from relative(s) able to understand information given and willing and able to voluntary give their consent to participate in this study.
- The subject will provide blood samples from the existing Aand/ or V-lines, and/or from a finger stick.
- Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
Exclusion
- Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- Subject, who is pregnant or breastfeeding.
- Subject, who has an invalid written informed consent or has withdrawn consent.
- Subject who has already provided successful measurements of arterial, venous and capillary samples, to cover both syringe modes and the capillary mode
- Subjects taking medications listed in Appendix 1 with last dose within 72 hours, should be excluded due to interference.
- Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
Key Trial Info
Start Date :
July 8 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2025
Estimated Enrollment :
754 Patients enrolled
Trial Details
Trial ID
NCT06078956
Start Date
July 8 2023
End Date
January 31 2025
Last Update
June 27 2025
Active Locations (1)
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1
UC Davis
Sacramento, California, United States, 95817