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NCT05873335 · ClinicalTrials.gov registry record · NA
In Vivo Pulse Oximeter Validation Study
A NA study, sponsored by Gabi SmartCare.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
NCT05873335 is a NA study that has completed, run by Gabi SmartCare. The registered enrollment target is 12 participants.
The verdict
NCT05873335, a NA study, has completed, sponsored by Gabi SmartCare.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
Study Summary
The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device A radial arterial cannula was placed in the wrist of each subject for arterial blood sampling and a subject device was placed on each arm of the patients. Then, hypoxia was induced to different stable levels of oxyhemoglobin saturation between 70-100% by having subjects breathe mixtures of nitrogen, air, and carbon dioxide controlled by the study physician. Values of SpO2 and SaO2 were then compared to provide a root mean square error and conclude on the subject device accuracy.
Interventions
- COMBINATION_PRODUCT Mixtures of nitrogen, air, and carbon dioxide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2023-02-28 |
| Est. Completion | 2023-03-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05873335
The ClinicalTrials.gov registry entry for NCT05873335 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Gabi SmartCare, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mixtures of nitrogen, air, and carbon dioxide is the first listed.
NCT05873335 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05873335 about?
NCT05873335 is a clinical study titled "In Vivo Pulse Oximeter Validation Study". The goal of this clinical trial is to compare values of SpO2 provided by the DUT and the SaO2 used as a reference in healthy adults. The main question it aims to answer is: what is the accuracy of the subject device compared to the 510(k)-cleared reference device A radial arterial cannula was place...
What is the current status of trial NCT05873335?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2023-02-28. Estimated completion is 2023-03-01.
What interventions are being tested in trial NCT05873335?
The interventions under investigation include: Mixtures of nitrogen, air, and carbon dioxide (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT05873335?
This trial is sponsored by Gabi SmartCare, which has 3 total clinical trials registered on ClinicalTrials.gov.
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