Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
612 participants
INTERVENTIONAL
2023-03-17
2024-01-30
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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.
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)
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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
1 Day
28 Days
ALL
Yes
Sponsors
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Radiometer Medical ApS
INDUSTRY
Responsible Party
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Principal Investigators
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Dennis Dietzen, PhD
Role: PRINCIPAL_INVESTIGATOR
St. Louis Children's Hospital
Locations
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St Louis Children's Hospital
St Louis, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DC-083185
Identifier Type: -
Identifier Source: org_study_id
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