ABL90 Flex Plus Method Comparison Study_Adults

NCT06078956 | Completed FDA Device

• 1 other identifier: DC-083659
• Study Type: interventional
• Target: 754
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diagnostic Test

Keywords

Blood gas

Outcome Measures

Primary Outcomes (1)

• Slope, R^2 and bias at medical decision points

  Primary Endpoints: Slope, R\^2 and bias at medical decision points for each combination of modes and sample type, across sites

  6-9 months

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

Device: Measuring of analytes

Predicate device

OTHER

Device: Measuring of analytes

Interventions

Measuring of analytes DEVICE

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.

Investigational Device; Predicate device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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• Subject, who has an invalid written informed consent or has withdrawn consent.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).

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Study Officials

• Lisbet Bærentzen, PhD

  Radiometer Medical ApS

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: October 12, 2023
• Study Start: July 8, 2023
• Primary Completion: December 1, 2024
• Study Completion: January 31, 2025
• Last Updated: June 27, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)