ABL90 Flex Plus Method Comparison Study_Adults

June 24, 2025 updated by: Radiometer Medical ApS

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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).

Study Type

Interventional

Enrollment (Actual)

754

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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  • Subject, who has an invalid written informed consent or has withdrawn consent.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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Investigational Device
Device: Measuring of analytes
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.
Other: Predicate device
Device: Measuring of analytes
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Radiometer Medical ApS

Investigators

  • Study Director: Lisbet Bærentzen, PhD, Radiometer Medical ApS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2023

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

October 9, 2023

First Posted (Actual)

October 12, 2023

Study Record Updates

Last Update Posted (Actual)

June 27, 2025

Last Update Submitted That Met QC Criteria

June 24, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DC-083659

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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