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ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

NCT06078943 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2023-10-12

No results posted yet for this study

Summary

The goal of this clinical trial is to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal arterial, venous, and capillary whole blood for ctBil and FHbF in a Point of Care (POC) setting.

Conditions

  • Congenital Heart Disease

Interventions

DEVICE

method comparison

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 ctBil and FHbF in heparinized arterial and venous neonatal whole blood in syringe measuring mode (S65, SP65) and heparinized mixed venous/arterial whole blood samples in capillary measuring mode (C65)

Sponsors & Collaborators

  • Radiometer Medical ApS

    lead INDUSTRY

Principal Investigators

  • Dennis Dietzen, PhD · St. Louis Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Day
Max Age
28 Days
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-03-17
Primary Completion
2024-01-13
Completion
2024-01-30
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 NCT06078943 on ClinicalTrials.gov