Diagnostic TestsNCT07860463
ABL90 FLEX PLUS Ki MC BASE Parameters
An observational study of Diagnostic Tests, run by Radiometer Medical ApS.
Trial summary
The purpose is a Method Comparison Study on ABL90 FLEX PLUS for BASE Parameters in Whole Blood Samples. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diagnostic Tests
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- Jan 2027to Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
About this study
Official title: 25009, ABL90 FLEX PLUS Ki Method Comparison Study for BASE Parameters in Whole Blood Samples
The purpose is a Method Comparison Study on ABL90 FLEX PLUS for BASE Parameters in Whole Blood Samples.
- Conditions
- Diagnostic Tests
What is being measured
The primary outcome is the main question the study is designed to answer.
Analytical Performance of ABL90 FLEX PLUS Ki.
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.
Measured: 6-8 month
Secondary outcomes (1)
Additional Characterization of Analytical Performance of ABL90 FLEX PLUS Ki.
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).
Measured: 6-8 month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diagnostic TestsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860463
- Sponsor's protocol ID
- DC-095150
- Status last verified
- Sep 2026
- First submitted
- 23 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No