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ABL90 FLEX PLUS Method Comparison Neonatal Capillary

NCT07051278 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 129

Last updated 2025-07-04

No results posted yet for this study

Summary

The study is intended to validate performance claims for method comparison for ABL90 FLEX PLUS in heparinized neonatal capillary whole blood for ctBil and FHbF in a POC setting

Conditions

  • Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects

Interventions

DEVICE

Method Comparison

Quantifying the relationship using comparison measurement from the same sample between ABL90 FLEX PLUS and the predicate device within the reportable range for ctBil and FHbF in heparinized capillary whole blood samples in capillary measuring mode (C65).

Sponsors & Collaborators

  • Radiometer Medical ApS

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-10
Primary Completion
2025-01-31
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 NCT07051278 on ClinicalTrials.gov