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New oxygen sensor tested for kids of all skin tones

NCT ID NCT07223177

Knowledge-focused Sponsor: Masimo Corporation Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jul 14, 2026 · Updated 3 times

Summary

This study checks if a new oxygen monitoring technology (Philips FAST SpO2) works well with Masimo sensors in children under 22 years old, including newborns. Researchers will compare its accuracy to an already-approved device and see how well the sensor fits. The goal is to ensure reliable readings across different skin colors.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could improve oxygen monitoring accuracy for babies and children in hospitals, especially across different skin pigmentations.
What could go wrong
This is a small, early-stage device verification study, not a treatment trial. It may not lead to any clinical changes or product improvements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

0 to 21 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subject falls within the indicated population for the Philips FAST SpO2 Monitor with the Masimo sensor. * Subject is less than 22 years of age (pediatric subject per US FDA definition). Exclusion Criteria: * Subject has a skin condition or deformity at the planned sensor application site, which would preclude sensor placement and measurements as standard of care (e.g., psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown). * Confounders of pulse oximetry per sensor direction for use (DFU). * Subject with distinct geographic variances in skin pigmentation (e.g., vitiligo), where the sensor is applied. * Subject has an absence or deformities of limbs or severe edema, which would interfere with sensor application or prevent the proper fit of the sensors. * Subject with nail polish or acrylic nails on the digits where sensor needs to be applied, who opts to not remove it. * Subject with known allergic reactions to adhesive tapes. * Subject is not suitable for the investigation at the discretion of the clinical research team.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

SPO2

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    2 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Paradigm Clinical Research

    RECRUITING

    Modesto, California, 95355, United States

  • Paradigm Clinical Research

    RECRUITING

    San Diego, California, 92108, United States

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