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

NCT05803694 | Completed FDA Device

• 2 other identifiers: DC-08447122003
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 2

Brief 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

Outcome Measures

Primary Outcomes (1)

• ABL90 FLEX PLUS Clinical Precision

  Repeatability (SD) for each parameter (ctBil and FHbF), parameter level and measuring mode, pooled across sites.

  5 hours

Interventions

ABL90 FLEX PLUS analyser running SW3.5 MR2. DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Pregnant women.
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation.

You may qualify if:

• Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section.
• Informed consent collected from subject able to understand information given, and willing and able to voluntarily give their consent to participate in this study.
• Subject evaluated by the principal investigator or designee as suitable for the study according to the protocol.

You may not qualify if:

• Subjects with known infectious disease such as Hepatitis C or HIV (to ensure the operator safety).

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (2)

Radiometer Medical

Copenhagen, Brønshøj, 2700, Denmark

Location

Ellen Løkkegaard

Hillerød, 3400, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples are collected to measure the ctBil and FHbF parameters in neonatal whole blood. Samples are destroyed when measurements are completed.

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2023
• First Posted: April 7, 2023
• Study Start: March 22, 2023
• Primary Completion: July 10, 2023
• Study Completion: September 6, 2023
• Last Updated: November 24, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: January 2025

Locations

DK (2)