ABL90 Flex Plus Method Comparison Study_Adults

Not Applicable

Recruiting

• Conditions: Diagnostic Test
• Interventions: Device: Measuring of analytes

• Registration Number: NCT06078956
• Lead Sponsor: Radiometer Medical ApS

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.

Detailed Description

The main question it aims to answer is:

To quantify the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for all 15 parameters in heparinized arterial and venous patient whole blood in syringe measuring mode (S65, SP65) and heparinized capillary whole blood samples in capillary measuring mode (C65).

Study Timeline

• Study Start: 2023-02-08
• Study First Submitted: 2023-02-14
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-12
• Last Update Posted: 2023-10-12
• Primary Completion: 2023-11-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

• 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.

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Exclusion Criteria

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• Subject, who has an invalid written informed consent or has withdrawn consent.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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Predicate device	Measuring of analytes	-
Investigational Device	Measuring of analytes	-

Primary Outcome Measures

Name	Time	Method
Slope, R^2 and bias at medical decision points	6-9 months	Primary Endpoints: Slope, R\^2 and bias at medical decision points for each combination of modes and sample type, across sites

Trial Locations

Locations (1)

UC Davis; 🇺🇸 Sacramento, California, United States