COMPLETED

ABL90 Flex Plus Method Comparison Study_Adults

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official 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.

Quick Facts

Study Start:2023-07-08

Study Completion:2025-01-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06078956

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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 * Subject, who has an invalid written informed consent or has withdrawn consent.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).

Inclusion Criteria

Exclusion 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.

* 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).

Contacts and Locations

Principal Investigator

Lisbet Bærentzen, PhD

STUDY_DIRECTOR

Radiometer Medical ApS

Study Locations (Sites)

UC Davis

Sacramento, California, 95817

United States

Collaborators and Investigators

Sponsor: Radiometer Medical ApS

Lisbet Bærentzen, PhD, STUDY_DIRECTOR, 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 Registration Dates

Study Start Date2023-07-08

Study Completion Date2025-01-31

Study Record Updates

Study Start Date2023-07-08

Study Completion Date2025-01-31

Terms related to this study

Keywords Provided by Researchers

Blood gas

Additional Relevant MeSH Terms

Diagnostic Test