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NCT05083351 · ClinicalTrials.gov registry record · NA

Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation

A NA study, sponsored by Masimo Corporation.

Completed
Registry status
NA
Development phase
88
Enrollment target

NCT05083351: Completed NA study, sponsored by Masimo Corporation.

NCT05083351 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 88 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.

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The verdict

NCT05083351, a NA study, has completed, sponsored by Masimo Corporation.

COMPLETED
Registry status
NA
Development phase
88 participants
Enrollment target

Study Summary

Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and skin pigmentation.

Primary Outcome

The SpO2 accuracy of the MightySat pulse oximeter was determined by calculating the root mean-squared (rms) difference between the measured values (SpO2) to the reference values (SaO2) in accordance with ISO-80601-2-61. Arms= √(∑(i=1 to n) ((SpO2\_i-SaO2\_i )\^2 ))/n.

Interventions

  • DEVICE MightySat

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2021-10-13
Est. Completion 2021-12-17
Phase NA
Masimo Corporation

96 total trials

What the finished NCT05083351 record still lists

NCT05083351 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 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 MightySat is the first listed.

NCT05083351 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT05083351 about?

NCT05083351 is a clinical study titled "Performance of Masimo MightySat Pulse Oximeter in Differing Levels of Skin Pigmentation". Evaluation of the noninvasive oxygen saturation (SpO2) performance of the noninvasive Masimo MightySat against reference arterial blood samples analyzed by a laboratory CO-oximeter reference instrument. The study will include different subgroups to assess the performance across different genders and...

What is the current status of trial NCT05083351?

This trial is currently completed. It is a NA study. The enrollment target is 88 participants. The study started on 2021-10-13. Estimated completion is 2021-12-17.

What interventions are being tested in trial NCT05083351?

The interventions under investigation include: MightySat (DEVICE).

Who is sponsoring clinical trial NCT05083351?

This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT05083351's enrollment target sits among peer trials

88 972nd of 2000 higher than 1,027 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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Source: ClinicalTrials.gov NCT05083351, the US trial registry maintained by the National Library of Medicine. NCT05083351 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.