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NCT05332392 · ClinicalTrials.gov registry record · NA
Clinical Performance of Masimo INVSENSOR00040
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 90
- Enrollment target
NCT05332392: Completed NA study, sponsored by Masimo Corporation.
NCT05332392 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 90 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05332392, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 90 participants
- Enrollment target
Study Summary
This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
Primary Outcome
SpO2 performance will be determined by calculating the arithmetic root square mean (ARMS) value through the comparison of the noninvasive SpO2 measurement obtained from INVSENSOR00040 to the arterial oxygen saturation (SaO2) value obtained from a reference blood sample. The square root of the sum of the squares of bias and precision is computed as the ARMS Error Value. The desaturation range over which the accuracy is performed is 70-100%.
Interventions
- DEVICE INVSENSOR00040
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 90 participants |
| Start Date | 2022-04-14 |
| Est. Completion | 2023-04-13 |
| Phase | NA |
What the finished NCT05332392 record still lists
NCT05332392 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 90 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00040 is the first listed.
NCT05332392 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05332392 about?
NCT05332392 is a clinical study titled "Clinical Performance of Masimo INVSENSOR00040". This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation and pulse rate to reference values obtained by a laboratory blood gas analyzer and a standard of care EKG monitor. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and ...
What is the current status of trial NCT05332392?
This trial is currently completed. It is a NA study. The enrollment target is 90 participants. The study started on 2022-04-14. Estimated completion is 2023-04-13.
What interventions are being tested in trial NCT05332392?
The interventions under investigation include: INVSENSOR00040 (DEVICE).
Who is sponsoring clinical trial NCT05332392?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05332392's enrollment target sits among peer trials
90 941st of 2000 higher than 1,029 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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