ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

NCT06078943 | Unknown FDA Device

• 1 other identifier: DC-083185
• Study Type: interventional
• Target: 612
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Blood gas

Outcome Measures

Primary Outcomes (1)

• Slope, R^2 and bias

  Slope, R\^2 and bias at medical decision points for each combination of modes and sample type

  6-9 months

Study Arms (2)

Investigational Device

ACTIVE COMPARATOR

The test device in this clinical study is the ABL90 FLEX PLUS running SW3.5 MR2 manufactured by Radiometer Medical ApS The analyzer provides results for 17 parameters in 35 seconds using 65 µL heparinized whole blood. However, in this investigation only the data concerning the parameters ctBil and FHbF will be evaluated.

Device: method comparison

Predicate device

SHAM COMPARATOR

The predicate device for this study is the unmodified device ABL90 FLEX PLUS (k160153) running software SW 3.1 MR7 including sensor casettes and solution packs versions corresponding to 2016. ABL90 FLEX PLUS SW 3.1 MR7, has been selected as the predicate device because it has the appropriate 510(k) clearance, and the intended use matches the ABL90 FLEX PLUS SW. SW3.5 MR2 device.

Device: method comparison

Interventions

method comparison DEVICE

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)

Investigational Device; Predicate device

Eligibility Criteria

• Age: 1 Day - 28 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• The age of the subject must be ≤28 days.
• Subject evaluated as suitable according to the protocol to enroll in the study by principal investigator or designee.
• Subjects having a sample drawn as part of standard of care that meets the requirements for samples in this study.
• Delivery ≥38 weeks of gestation.

You may not qualify if:

• Subject who has already provided successful results from arterial, venous and mixed venous/arterial samples, to cover both syringe modes and the capillary mode and parameters.
• Subjects exposed to the substances listed in Appendix 1 with last dose within 72 hours, should be excluded due to risk of interference.
• Subjects with known infectious disease such as Hepatitis C and HIV (in order to ensure the operator safety).
• Subjects positive of HIV or Hepatitis C

Sponsors & Collaborators

• Radiometer Medical ApS: lead

Study Sites (1)

St Louis Children's Hospital

St Louis, Missouri, 63110, United States

RECRUITING

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Dennis Dietzen, PhD

  St. Louis Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lone Pedersen, PhD

CONTACT

+4528989640; lone.graasboljuulpedersen@radiometer.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2023
• First Posted: October 12, 2023
• Study Start: March 17, 2023
• Primary Completion: January 13, 2024
• Study Completion: January 30, 2024
• Last Updated: October 12, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)