MedDataX Logo

25010 - ABL90 FLEX PLUS - Precision Capillary Adult - Clinical Study Protocol

NCT ID: NCT07307352

Last Updated: 2025-12-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-08

Study Completion Date

2026-02-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 (Figure 1) 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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Diagnostic Tests

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ABL90

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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

Exclusion Criteria

* 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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Radiometer Medical ApS

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Klaus T Kristiansen, MD

Role: PRINCIPAL_INVESTIGATOR

Hvidovre Hospital, ICU

Lars Peter k Andersen, MD

Role: PRINCIPAL_INVESTIGATOR

Sjællands Universitetshospital Køge, Centre for Anaesthesiology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hvidovre Hospital

Hvidovre, , Denmark

Site Status

Sjællands Universitets Hospital Køge

Køge, , Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Helle H Petersen

Role: CONTACT

Phone: +4529259390

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Klaus T Kristiansen, MD

Role: primary

Lars Peter K Andersen, MD

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

25010

Identifier Type: -

Identifier Source: org_study_id