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ABL90 Flex Plus Method Comparison Study_Adults

NCT06078956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 754

Last updated 2025-06-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • Radiometer Medical ApS

    lead INDUSTRY

Principal Investigators

  • Lisbet Bærentzen, PhD · Radiometer Medical ApS

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-07-08
Primary Completion
2024-12-01
Completion
2025-01-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078956 on ClinicalTrials.gov