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ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood

NCT05803694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 54

Last updated 2023-11-24

No results posted yet for this study

Summary

Conducting the ABL90 FLEX PLUS Clinical Precision Study for ctBil and FHbF Parameters in Neonatal Whole Blood is to validate performance claims for precision of the ABL90 FLEX PLUS ctBil and FHbF parameters in neonatal whole blood while being influenced by testing environment that is representative of intended use environment, site variability, intended use testing environment and operator variability in a Point-of-Care (POC) setting.

The investigational device is the ABL90 FLEX PLUS incl. consumables, running SW3.5 MR2, manufactured by Radiometer Medical ApS.

The study is being conducted in Denmark and in total, a minimum of 54 subjects are to be enrolled to provide successful measurement values from 3 different sites.

Conditions

  • Blood Tests

Interventions

DEVICE

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.

Sponsors & Collaborators

  • Radiometer Medical ApS

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2023-07-10
Completion
2023-09-06
FDA Device
Yes

Countries

  • Denmark

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 NCT05803694 on ClinicalTrials.gov