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NCT03630016 · ClinicalTrials.gov registry record · NA
SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry
A NA study, sponsored by Owlet Baby Care.
- Completed
- Registry status
- NA
- Development phase
- 11
- Enrollment target
NCT03630016 is a NA study that has completed, run by Owlet Baby Care. The registered enrollment target is 11 participants.
The verdict
NCT03630016, a NA study, has completed, sponsored by Owlet Baby Care.
- COMPLETED
- Registry status
- NA
- Development phase
- 11 participants
- Enrollment target
Study Summary
Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available over-the-counter), with specific emphasis on its pulse oximetry accuracy. The BabySat and Smart SockTM 2 are non-invasive home care devices for use with infants. The purpose of this study was to validate the SpO2 accuracy of BabySat v1.0 and Owlet Smart SockTM 2, OSS v1.1 sensors pulse oximetry, during non-motion conditions over the range of 70-100% SaO2 as compared to arterial blood samples assessed by CO-Oximetry.
Interventions
- DIAGNOSTIC_TEST Pulse oximetry with Owlet BabySat v1.0 sensor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 11 participants |
| Start Date | 2017-12-13 |
| Est. Completion | 2017-12-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03630016
The ClinicalTrials.gov registry entry for NCT03630016 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 11 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Owlet Baby Care, which has 9 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Pulse oximetry with Owlet BabySat v1.0 sensor is the first listed.
NCT03630016 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03630016 about?
NCT03630016 is a clinical study titled "SpO2 Accuracy Comparison of Smart Sock V. 2 SpO2 to Arterial Blood CO-Oximetry". Pulse oximetry monitoring is considered a standard physiological measurement and is used by clinicians in everyday situations to estimate arterial oxygen saturation. There are two devices used in this investigational study: BabySat v.1.0 and Owlet Baby Care, Inc. Smart SockTM 2 (currently available ...
What is the current status of trial NCT03630016?
This trial is currently completed. It is a NA study. The enrollment target is 11 participants. The study started on 2017-12-13. Estimated completion is 2017-12-17.
What interventions are being tested in trial NCT03630016?
The interventions under investigation include: Pulse oximetry with Owlet BabySat v1.0 sensor (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT03630016?
This trial is sponsored by Owlet Baby Care, which has 9 total clinical trials registered on ClinicalTrials.gov.
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