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Completed

NCT Number: NCT06078956

ABL90 Flex Plus Method Comparison Study_Adults

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 and FHHb in heparinized whole blood in a Point of Care (POC) setting.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UC Davis

Sacramento, California, 95817, United States

About this study

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 all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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  • Subject, who has an invalid written informed consent or has withdrawn consent.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).

Treatment and study plan

Measuring of analytes

Device

Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in whole blood in adult population.

Primary outcomes

  1. Slope, R^2 and bias at medical decision points

    Time frame: 6-9 months

    Primary Endpoints: Slope, R^2 and bias at medical decision points for each combination of modes and sample type, across sites

Sponsors and collaborators

Lead sponsor

Radiometer Medical ApS

Industry

Registry information

Official study title

ABL90 FLEX PLUS Method Comparison Study for pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb in Whole Blood in Adult Population.

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Oct 12, 2023
Registry last updated
Jun 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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