ABL90 FLEX PLUS Method Comparison Neonatal Capillary

Not Applicable

Completed

• Conditions: Method Comparison for ABL90 FLEX PLUS in Neonatal Subjects

• Registration Number: NCT07051278
• Lead Sponsor: Radiometer Medical ApS

Brief 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

Detailed Description

The objective is to perform a method comparison study to quantify 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).

This study will together with a method comparison study performed with surrogate capillary samples contribute to the overall validation of the performance of ABL90 FLEX for capillary whole blood with regards to the parameters ctBil and FHbF measured using the capillary mode.

This study is anticipated to run for approximately 6-12 months from site initiation visit till close-out visit depending on patient enrollment.

Study Timeline

• Study Start: 2023-11-10
• Study First Submitted: 2024-05-30
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-06
• Study First Submitted QC: 2025-06-30
• Last Update Submitted: 2025-06-30
• Study First Posted: 2025-07-04
• Last Update Posted: 2025-07-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 129

Inclusion Criteria

• Informed consent collected from legal representative able to understand information given and willing and able to voluntary give their consent to participate in this study.
• The age of the subject must be ≤28 days.
• Subject evaluated as suitable according to the protocol to enrol 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• Subject, who has an invalid written informed consent or has withdrawn consent.
• Subject who has already provided successful results from capillary samples, to cover both parameters.
• Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Primary Endpoints	12 months	Bias between device under investigation and comparative device at medical decision level across sites; (unit is mg/dL)

Secondary Outcome Measures

Name	Time	Method
Secondary Endpoints	12 months	Bias between device under investigation and comparative device at a medical decision point in native capillary samples per site; (unit is mg/dL)

Trial Locations

Locations (3)

Albert Einstein College of Medicine; 🇺🇸 Bronx, New York, United States

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States