ABL90 Flex Plus Method Comparison Study_Adults

ABL90 FLEX PLUS 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.

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.

Study Overview

• Status: Recruiting
• Conditions: Diagnostic Test
• Intervention / Treatment: Device: Measuring of analytes

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 Type: Interventional
• Enrollment (Estimated): 360
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lone GJ Pedersen, PhD; Phone Number: +4528989640; Email: lone.graasboljuulpedersen@radiometer.dk

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817
      • Recruiting
      • UC Davis
      • Contact: Nam Tran, PhD; Phone Number: 916-734-2525; Email: nktran@ucdavis.ed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

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• Subject, who has an invalid written informed consent or has withdrawn consent.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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Investigational Device	Device: Measuring of analytes; 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.
Other: Predicate device	Device: Measuring of analytes; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS
• Investigators: Study Director: Lisbet Bærentzen, PhD, Radiometer Medical ApS

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2023
• Primary Completion (Estimated): November 30, 2023
• Study Completion (Estimated): December 30, 2023

Study Registration Dates

• First Submitted: February 14, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 12, 2023

Study Record Updates

• Last Update Posted (Actual): October 12, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Blood gas
• Other Study ID Numbers: DC-083659

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes