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

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.

Study Overview

• Status: Recruiting
• Conditions: Blood Tests
• Intervention / Treatment: Device: ABL90 FLEX PLUS analyser running SW3.5 MR2.

Detailed Description

The conduct of the clinical study is to determine the repeatability of ctBil and FHbF parameters in neonatal whole blood using contrived fetal cord blood from umbilical cord/placenta measured by the intended users in syringe, short probe, and capillary modes available for ABL90 FLEX PLUS, in a POC setting.

The primary endpoint is the Repeatability (SD) for each parameter, parameter level and measuring mode, pooled across sites.

Participating sites are maternity wards or similar site conducting planned cesarean sections. Pregnant women 18 years of age or older admitted to the maternity ward to undergo cesarian section after week 38 of gestation will be enrolled in the clinical study. When the subject has signed ICF, the site will collect cord blood from umbilical cord/placenta and when relevant prepare contrived samples by having access to adult type 0 Rh neg whole blood for diluting HbF in cord blood.

Three POC users, such as a nurse, a physician, or a therapist that care for the woman in the maternity ward will perform all measurements and they shall contribute evenly to the total number of samples measured. Replicate measurements shall be performed by the same user.

6-10 mL of cord blood is collected in a blood collection syringe from each umbilical cord/placenta, contrived, and the sample is aliquoted into 5 safePICO aspirators (max volume 1.5 mL) or into 25 capillary tubes.

At each site, samples will be collected for the 2 parameters, 3 modes and 3 levels, completing measurements from minimum of 18 samples from 18 subjects.

• Study Type: Observational
• Enrollment (Estimated): 54

Contacts and Locations

• Study Contact: Name: Charlotte Lindgreen; Phone Number: 20638305; Email: charlotte.lindgreen@Radiometer.dk
• Study Contact Backup: Name: Sara Matzen, PM; Phone Number: +45 60469639; Email: sara.matzen@radiometer.dk

Study Locations

• Denmark
  • Hillerød, Denmark, 3400
    • Recruiting
    • Ellen Løkkegaard
    • Contact: Ellen Løkkegaard; Phone Number: +45 48296249; Email: Ellen.Christine.Leth.Loekkegaard@regionh.dk
    • Contact: Ida Karoline Bach Jensen; Phone Number: +45 50520953; Email: ida.karoline.bach.jensen.01@regionh.dk
  • Brønshøj
    • Copenhagen, Brønshøj, Denmark, 2700
      • Not yet recruiting
      • Radiometer Medical
      • Contact: Sara Matzen, PM; Phone Number: +45 60469639; Email: sara.matzen@radiometer.dk
      • Principal Investigator: Ellen Løkkegaard, MD Professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ABL90 FLEX PLUS Clinical Precision	Repeatability (SD) for each parameter (ctBil and FHbF), parameter level and measuring mode, pooled across sites.	5 hours

Collaborators and Investigators

• Sponsor: Radiometer Medical ApS

Study record dates

Study Major Dates

• Study Start (Actual): March 22, 2023
• Primary Completion (Actual): July 10, 2023
• Study Completion (Estimated): July 31, 2024

Study Registration Dates

• First Submitted: March 25, 2023
• First Submitted That Met QC Criteria: March 25, 2023
• First Posted (Actual): April 7, 2023

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: DC-084471; 22003 (Other Identifier: Radiometer)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: When the Clinical Study Report has been finalized, Data result will be available for public on platforms and in articles.
• IPD Sharing Time Frame: January 2025
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No