Diagnostic TestsNCT07307352
25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol
An observational study of Diagnostic Tests, run by Radiometer Medical ApS at 2 sites in Denmark.
Trial summary
Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnostic Tests
- What is being tested?
- ABL90 FLEX PLUS analyser running SW3.5 MR2.
- Type of treatment
- Injection or infusion
- How many people
- 39 participants
- Where
- 2 sitesDenmark
- Study dates
- 20 Jan 2026to 30 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years old ) admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible.
Who may be able to join
- The subject must be 18 years or older.
- Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
- Subject evaluated as suitable according to the protocol to enroll in the study by the principal investigator or designee
Who cannot join
- Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- Subject, with known pregnancy or breastfeeding.
- Subject, who has an invalid written informed consent or has withdrawn consent.
- Subjects who have been previously enrolled in the study.
- Subjects exposed to following substances within the last 72 hours:
- Acetylsalicylic Acid Sodium Salt at dose equal or above 1 gram/day
- N-acetylcysteine o Fluorescein dye o Patent Blue dye -
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Hvidovre Hospital
Hvidovre, 2650
Sjællands Universitets Hospital Køge
Køge, 4600
About this study
Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.
Read the detailed description
Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65).
The study is designed to collect approximately 30 pairs of samples combined across sites.
- Conditions
- Diagnostic Tests
- Being tested
- ABL90 FLEX PLUS analyser running SW3.5 MR2.
- Keywords
- ABL90
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABL90 FLEX PLUS analyser running SW3.5 MR2.Diagnostic test
The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, metabolites, and oximetry in whole blood - utilizing 3 measuring modes (syringe, short probe, and capillary mode) to measure samples from a syringe, test tube or a capillary tube. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood.
What is being measured
The primary outcome is the main question the study is designed to answer.
Within sample precision for each parameter measured in capillary mode pooled across sites.
Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.
Measured: 1 hour
Secondary outcomes (1)
Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2025
- Study start20 Jan 2026
- Primary completion30 Jan 2026
- Study completion30 Jan 2026
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Klaus T Kristiansen, MD, Principal investigator, Hvidovre Hospital, ICULars Peter k Andersen, MD, Principal investigator, Sjællands Universitetshospital Køge, Centre for Anaesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07307352
- Sponsor's protocol ID
- 25010
- Status last verified
- Feb 2026
- First submitted
- 15 Dec 2025
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The clinical study results will be submitted to clinical trial.gov after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol
- ClinicalTrials.gov ID
- NCT07307352
- Acronym / sponsor ID
- 25010
- Conditions
- Diagnostic Tests
- Keywords
- ABL90
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 30 Jan 2026 (actual)
- Study completion
- 30 Jan 2026 (actual)
- First posted
- 29 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Conducting the ABL90 FLEX PLUS Clinical Precision Study for 15 Parameters in Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS The study is being conducted in Denmark and in total, a minimum of 30 subjects are to be enrolled to provide successful measurement values from 2 sites.
Detailed description
Adult Whole Blood is to validate performance claims for precision in heparinized whole blood for 15 parameters: pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb, and FHHb, while being influenced by testing environment that is representative of intended use environment, site variability, and operator variability in a point-of-care (POC) setting.
Capillary blood collected into 2 capillary tubes from 2 distinct finger sticks will be measured on ABL90 FLEX PLUS in the Capillary mode (C65).
The study is designed to collect approximately 30 pairs of samples combined across sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old ) admitted to the hospital with low (moderate hypo), normal, or elevated (moderate hyper) concentrations of the 15 parameters covering the reportable range as much as possible.
Key inclusion criteria (3 listed)
- The subject must be 18 years or older.
- Subjects must be able to understand given information and demonstrate willingness and ability to voluntarily give a signed, valid written informed consent to participate in the study.
- Subject evaluated as suitable according to the protocol to enroll in the study by the principal investigator or designee
Key exclusion criteria (7 listed)
- Subject where sample collection is evaluated by principal investigator or designee to impose an unnecessary risk.
- Subject, with known pregnancy or breastfeeding.
- Subject, who has an invalid written informed consent or has withdrawn consent.
- Subjects who have been previously enrolled in the study.
- Subjects exposed to following substances within the last 72 hours:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ABL90 FLEX PLUS analyser running SW3.5 MR2.The ABL90 FLEX PLUS analyzer is a portable, automated analyzer that measures pH, blood gases, electrolytes, metabolites, and oximetry in whole blood - utilizing 3 measuring modes (syringe, short probe, and capillary mode) to measure samples from a syringe, test tube or a capillary tube. The analyzer provides results for 17 parameters in 35 seconds using 65 μL heparinized whole blood. | Diagnostic test | – |
Primary outcome
Within sample precision for each parameter measured in capillary mode pooled across sites.
Time frame: 1 hour
Within sample precision of each parameter (pH, pCO2, pO2, cCa2+, cCl-, cK+, cNa+, cGlu, cLac, ctHb, sO2, FO2Hb, FMetHb, FCOHb and FHHb) using replicate measurements from heparinized whole blood samples measured by intended users in a POC setting.
1 secondary outcome
Within sample precision for each parameter measured in capillary mode per site, if applicable (at least 15 degrees of freedom shall be obtained for the estimate to be statistically meaningful).
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No. The clinical study results will be submitted to clinical trial.gov after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Klaus T Kristiansen, MD principal investigator
Hvidovre Hospital, ICU
Lars Peter k Andersen, MD principal investigator
Sjællands Universitetshospital Køge, Centre for Anaesthesiology
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diagnostic Tests, run by Radiometer Medical ApS at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Within sample precision for each parameter measured in capillary mode pooled across sites. (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.