Clinical Trial on Diagnostic Tests - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Diagnostic Tests

Study Type

Observational

Enrollment (Estimated)

300

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult in- and out-patients under standard of care to cover the reportable range of the parameters. Apparently healthy individuals may also provide samples through volunteer venipuncture to cover normal levels and for contriving.

Description

Inclusion Criteria:

The subject must be 18 years or older.
Informed consent obtained from subject able to understand information given and willing and able to voluntary give their consent to participate. Where the subject cannot provide informed consent, informed consent is obtained from the legally authorized/designated representative, once they have been fully informed.
For arterial and venous blood draw, the subject must have existing arterial and/or venous lines or undergo venipuncture as part of standard of care (criteria not appliable to apparently healthy individuals donating blood via venipuncture).

Exclusion Criteria:

Subjects who have previously provided successful measurements of arterial or venous samples for this study.
Subjects for whom the investigator (or designee) evaluates that sample collection would pose an unnecessary or unacceptable safety risk.

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

Observational Models: CASE_ONLY
Time Perspectives: CROSS_SECTIONAL

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Analytical Performance of ABL90 FLEX PLUS Ki. Time Frame: 6-8 month	Analytical performance of the ABL90 FLEX PLUS Ki for pH, pCO₂, pO₂, cNa⁺, cK⁺, cCa²⁺, cCl-, cGlu, and cLac. Analytical performance will be assessed by: agreement with the comparator method, evaluated by bias and corresponding 95% confidence intervals at predefined medical decision levels using regression analyses; and repeatability, evaluated as standard deviation (SD) or coefficient of variation (CV), as applicable, with corresponding 95% confidence intervals. Analyses will be performed separately for arterial and venous blood samples using data combined across study site.	6-8 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Additional Characterization of Analytical Performance of ABL90 FLEX PLUS Ki. Time Frame: 6-8 month.	Additional characterization of analytical performance through site-specific analyses of bias and repeatability, and evaluation of the relationship between the ABL90 FLEX PLUS Ki and the comparator method using regression slope, corresponding 95% confidence intervals, and coefficient of determination (R²).	6-8 month.

Collaborators and Investigators

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

Sponsor

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 (Estimated)

January 1, 2027

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

September 23, 2026

First Submitted That Met QC Criteria

October 1, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)