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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: Completed NA study, sponsored by Gabi SmartCare.
NCT05873335 is a NA study that has completed, run by Gabi SmartCare. The registered enrollment target is 12 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Arms, given in percentage or rms error, is the calculation of root mean square between SpO2 values from the subject device and the SaO2 from the Hemoximeter. It is a way of averaging the absolute values of errors over the full measurement range and is a similar measurmeent to a "rms error". It indicates how far (accurate) the provided value is from the reference used.
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 |
What the finished NCT05873335 record still lists
NCT05873335 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which Mixtures of nitrogen, air, and carbon dioxide is the first listed.
NCT05873335 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05873335's enrollment target sits among peer trials
12 1913th of 2000 higher than 74 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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