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NCT04964609 · ClinicalTrials.gov registry record · NA
EmbracePlus SpO2 Accuracy Validation
A NA study, sponsored by Empatica.
- Completed
- Registry status
- NA
- Development phase
- 14
- Enrollment target
NCT04964609: Completed NA study, sponsored by Empatica.
NCT04964609 is a NA study that has completed, run by Empatica. The registered enrollment target is 14 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
NCT04964609, a NA study, has completed, sponsored by Empatica.
- COMPLETED
- Registry status
- NA
- Development phase
- 14 participants
- Enrollment target
Study Summary
The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subject device during brief, steady state hypoxia with a gold-standard measurement of blood oxyhemoglobin (hemoglobin carrying oxygen) saturation, that is arterial blood sample processed in a laboratory.
Primary Outcome
SpO2 as measured by the subject device during periods of low motion will be compared to the oxyhemoglobin saturation (SaO2) as measured by direct oximetry with a Radiometer ABL-90 multi-wavelength oximeter
Interventions
- DEVICE EmbracePlus
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 14 participants |
| Start Date | 2021-06-16 |
| Est. Completion | 2022-11-21 |
| Phase | NA |
What the finished NCT04964609 record still lists
NCT04964609 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 14 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 EmbracePlus is the first listed.
NCT04964609 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04964609 about?
NCT04964609 is a clinical study titled "EmbracePlus SpO2 Accuracy Validation". The aim of this study is to test the accuracy of EmbracePlus computed SpO2 during mild, moderate and severe hypoxia (a lower-than-normal concentration of oxygen in arterial blood); ie, a range of arterial HbO2 saturations from 100 to down to 70%. This is done by comparing the reading of the the subj...
What is the current status of trial NCT04964609?
This trial is currently completed. It is a NA study. The enrollment target is 14 participants. The study started on 2021-06-16. Estimated completion is 2022-11-21.
What interventions are being tested in trial NCT04964609?
The interventions under investigation include: EmbracePlus (DEVICE).
Who is sponsoring clinical trial NCT04964609?
This trial is sponsored by Empatica, which has 3 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04964609's enrollment target sits among peer trials
14 1909th of 2000 higher than 90 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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