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Blood Measurement Device Accuracy for Congenital Heart Disease

N/A

Recruiting

Led By Dennis Dietzen, PhD

Research Sponsored by Radiometer Medical ApS

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months

Awards & highlights

Study Summary

This trial tests an accuracy of a device to measure neonatal blood levels in a medical setting.

Who is the study for?

This trial is for newborns up to 28 days old, born at or after 38 weeks of gestation. They must be deemed suitable by the investigator and have a standard care sample that fits the study's needs. Newborns who've already given successful blood samples or been exposed to certain substances recently, as well as those with infectious diseases like Hepatitis C or HIV, cannot participate.Check my eligibility

What is being tested?

The trial aims to validate performance claims for ABL90 FLEX PLUS—a method comparison tool used on heparinized neonatal arterial, venous, and capillary whole blood—in a Point of Care setting. It focuses on two parameters: ctBil (total bilirubin) and FHbF (fetal hemoglobin fraction).See study design

What are the potential side effects?

Since this trial involves testing an analytical method rather than a drug or therapy, there are no direct side effects from interventions being studied. However, routine risks associated with drawing blood in neonates apply.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-9 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-9 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Slope, R^2 and bias

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Investigational DeviceActive Control1 Intervention

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.

Group II: Predicate devicePlacebo Group1 Intervention

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Radiometer Medical ApSLead Sponsor

7 Previous Clinical Trials

3,056 Total Patients Enrolled

Dennis Dietzen, PhDPrincipal InvestigatorSt. Louis Children's Hospital

1 Previous Clinical Trials

171 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals aged over 30 eligible to participate in this trial?

"The minimum and maximum ages for inclusion in the project were laid out as 1 Day and 28 Days respectively."

Answered by AI

Is there capacity for additional participants within this clinical examination?

"Clinicaltrials.gov indicates that recruitment for this medical trial is open to the public, as it was posted on March 17th 2023 and last updated October 9th of the same year."

Answered by AI

Who would be a suitable candidate for participating in this medical study?

"To qualify, a person must possess congenital heart disease and range in age from newborn to 28 days old. This trial has the capacity for 612 patients across multiple sites."

Answered by AI

How many people will be included in the experimental procedure?

"Affirmative. The clinicaltrials.gov website maintains the information that this trial was first posted on March 17th of 2023 and is now actively recruiting participants - 612 in total from one site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood

2023. "ABL90 FP MC Neonatal Arterial, Venous, Capillary Blood". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078943.