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ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

Primary Purpose

Congenital Heart Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
method comparison
Sponsored by
Radiometer Medical ApS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Congenital Heart Disease focused on measuring Blood gas

Eligibility Criteria

1 Day - 28 Days (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • St Louis Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Investigational Device

Predicate device

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
October 9, 2023
Sponsor
Radiometer Medical ApS
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1. Study Identification

Unique Protocol Identification Number
NCT06078943
Brief Title
ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
Official Title
ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 17, 2023 (Actual)
Primary Completion Date
January 13, 2024 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Radiometer Medical ApS

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Heart Disease
Keywords
Blood gas

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
612 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Investigational Device
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Predicate device
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
method comparison
Intervention Description
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)
Primary Outcome Measure Information:
Title
Slope, R^2 and bias
Description
Slope, R^2 and bias at medical decision points for each combination of modes and sample type
Time Frame
6-9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lone Pedersen, PhD
Phone
+4528989640
Email
lone.graasboljuulpedersen@radiometer.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis Dietzen, PhD
Organizational Affiliation
St. Louis Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
St Louis Children's Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dennis Dietzen, PhD, DABCC, FAACC
Phone
314-362-6586
Email
dietzen_d@wustl.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

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