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Point of Care Device Accuracy for Blood Measurement

N/A

Recruiting

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 older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-9 months

Awards & highlights

Study Summary

This trial aims to see if a Point of Care medical device can accurately measure blood components with heparinized whole blood.

Who is the study for?

This trial is for adults over 18 who can give informed consent and are able to provide blood samples from existing lines or a finger stick. It's not for pregnant/breastfeeding individuals, those at unnecessary risk from sample collection, anyone with invalid consent, subjects who've completed certain sample collections already, those recently on interfering medications listed in an appendix, or with infectious diseases like Hepatitis C and HIV.Check my eligibility

What is being tested?

The study is testing the ABL90 FLEX PLUS device's ability to measure various blood components (like gases, electrolytes, sugars) accurately in adult patients within a Point of Care setting. The goal is to confirm if the device's performance matches its claims when used on heparinized whole blood samples.See study design

What are the potential side effects?

Since this trial involves standard procedures for drawing blood and measuring analytes without introducing any drugs or invasive treatments into the body, significant side effects are not expected beyond typical risks associated with blood sampling such as pain or bruising at the puncture site.

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 at medical decision points

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Predicate deviceExperimental Treatment1 Intervention

Group II: Investigational DeviceActive Control1 Intervention

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Radiometer Medical ApSLead Sponsor

7 Previous Clinical Trials

3,308 Total Patients Enrolled

1 Trials studying Diagnostic Test

100 Patients Enrolled for Diagnostic Test

Lisbet Bærentzen, PhDStudy DirectorRadiometer Medical ApS

Frequently Asked Questions

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

What is the size of the cohort involved in this research project?

"Correct. According to data hosted on clinicaltrials.gov, this clinical trial is actively recruiting participants since its creation on February 8th 2023 and last update of October 9th 2023. 360 individuals are needed at a single location for the study's completion."

Answered by AI

Is this investigation in need of more participants?

"Yes, the online resource clinicaltrials.gov confirms that recruitment for this trial is in progress, commencing on February 8th 2023 and most recently updated October 9th 2023. This medical research project needs 360 participants from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

ABL90 Flex Plus Method Comparison Study_Adults

2023. "ABL90 Flex Plus Method Comparison Study_Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06078956.