ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Sponsor

Radiometer Medical ApS (Industry)

Overall Status

Recruiting

CT.gov ID

NCT06078943

Collaborator

(none)

612

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

58.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Congenital Heart Disease	Device: method comparison	N/A

Detailed Description

The main question it aims to answer is:

To quantify the relationship using comparison measurement from the same sample between the test device and the predicate device within the reportable range for 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).

Study Design

Study Type:

Interventional

Anticipated Enrollment :

612 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood

Actual Study Start Date :

Mar 17, 2023

Anticipated Primary Completion Date :

Jan 13, 2024

Anticipated Study Completion Date :

Jan 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Investigational Device 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 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)
Sham Comparator: Predicate device 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 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)

Arm

Intervention/Treatment

Active Comparator: Investigational Device

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

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)

Sham Comparator: Predicate device

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

Outcome Measures

Primary Outcome Measures

Slope, R^2 and bias [6-9 months]
Slope, R^2 and bias at medical decision points for each combination of modes and sample type

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Day to 28 Days

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

The following are the inclusion criteria for the neonatal subjects:
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.

The following are the inclusion criteria for the subjects providing placenta for cord blood:

• Delivery ≥38 weeks of gestation.

Exclusion Criteria:

The following are the exclusion criteria for the neonatal subjects:
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).

The following are the exclusion criteria for the subjects providing placenta for cord blood:

• Subjects positive of HIV or Hepatitis C

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	St Louis Children's Hospital	Saint Louis	Missouri	United States	63110

Sponsors and Collaborators

Radiometer Medical ApS

Investigators

Principal Investigator: Dennis Dietzen, PhD, St. Louis Children's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Radiometer Medical ApS

ClinicalTrials.gov Identifier:

NCT06078943

Other Study ID Numbers:

DC-083185

First Posted:

Oct 12, 2023

Last Update Posted:

Oct 12, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Keywords provided by Radiometer Medical ApS

Blood gas

Additional relevant MeSH terms:

Heart Diseases

Heart Defects, Congenital

Study Results

No Results Posted as of Oct 12, 2023