Congenital Heart DiseaseNCT06078943
ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood
A study testing method comparison in people with Congenital Heart Disease, run by Radiometer Medical ApS at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 day to 28 daysHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- method comparison
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 612 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Mar 2023to 30 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 28 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
St Louis Children's Hospital
St Louis, Missouri, 63110
Dennis Dietzen, PhD, DABCC, FAACC, 314-362-6586, dietzen_d@wustl.edu
About this study
Official title: ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
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.
Read the 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).
- Conditions
- Congenital Heart Disease
- Being tested
- method comparison
- Keywords
- Blood gas
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
method comparisonDevice
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)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: method comparison |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope, R^2 and bias
Slope, R^2 and bias at medical decision points for each combination of modes and sample type
Measured: 6-9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2023
- Study start17 Mar 2023
- Primary completion13 Jan 2024 (estimated)
- Study completion30 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 612 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radiometer Medical ApS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis Dietzen, PhD, Principal investigator, St. Louis Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06078943
- Sponsor's protocol ID
- DC-083185
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ABL90 Flex Plus Method Comparison Neonatal Arterial, Venous, Capillary Blood
- ClinicalTrials.gov ID
- NCT06078943
- Acronym / sponsor ID
- DC-083185
- Conditions
- Congenital Heart Disease
- Keywords
- Blood gas
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 612 participants (estimated)
- Lead sponsor
- Radiometer Medical ApSIndustry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 13 Jan 2024 (estimated)
- Study completion
- 30 Jan 2024 (estimated)
- First posted
- 12 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational Device | Active comparator | Device: method comparisonThe 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. |
| Predicate device | Sham comparator | Device: method comparisonThe 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. |
Who may qualify
- Ages
- 1 day to 28 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- The following are the inclusion criteria for the neonatal subjects:
- The following are the inclusion criteria for the subjects providing placenta for cord blood:
- Delivery ≥38 weeks of gestation.
Key exclusion criteria (6 listed)
- The following are the exclusion criteria for the neonatal subjects:
- The following are the exclusion criteria for the subjects providing placenta for cord blood:
- Subjects positive of HIV or Hepatitis C
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| method comparisonto 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) | Device | Investigational Device, Predicate device |
Primary outcome
Slope, R^2 and bias
Time frame: 6-9 months
Slope, R^2 and bias at medical decision points for each combination of modes and sample type
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis Dietzen, PhD principal investigator
St. Louis Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing method comparison in people with Congenital Heart Disease, run by Radiometer Medical ApS at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lone Pedersen, PhD (+4528989640, lone.graasboljuulpedersen@radiometer.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Slope, R^2 and bias (time frame: 6-9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2023.