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Can a Stick-On sensor replace the thermometer?

NCT ID NCT06289556

Diagnosis 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 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 Results may not be published yet.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 This study
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This status has not been confirmed recently, so it may be out of date.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 Aug 25, 2026 · Last updated Aug 26, 2026 · Updated 1 time

Summary

This trial tests how well a new noninvasive sensor, called Masimo INVSENSOR00048, measures body temperature compared to standard thermometers. It includes people of all ages, both with and without fever. The goal is to see if the sensor's readings are accurate enough for clinical use.

What this could mean

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

Active substance
Masimo INVSENSOR00048, a noninvasive temperature sensor
What this could lead to
If successful, this could lead to a more comfortable, noninvasive way to monitor body temperature in hospitals and homes.
What could go wrong
The trial is early and focuses on measurement accuracy, not health outcomes. The sensor may not match the precision of standard thermometers in all cases.

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.

Participants

180 people

The number who actually took part.

Started

Jan 2024

Finished

May 2025

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Afebrile subjects of all ages, or febrile subjects of all ages who meet the following criteria for screening temperature: * sublingual temperature ≥ 37.5°C (99.5°F), * rectal temperature ≥ 38.0°C (100.4°F), * or axillary temperature ≥ 37.2°C (99.0°F) * If subject is \< 18 years old, parents or legally authorized representatives (LAR) have provided informed consent and have signed all necessary related documents Exclusion Criteria: * Subjects with medical conditions such as inflammation at the measuring site or taking medications e.g. barbiturates, thyroid preparations, antipsychotics, or immunization within prior 7 days, which might skew clinical accuracy validation results such as, per the investigator's judgement * Subjects unable to provide informed consent or assent, as appropriate * Subjects with conditions at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown that would prevent monitoring of physiological parameters during the study * Subjects with known allergies to adhesive material used in medical equipment * Subjects with medical conditions which, in the judgment of the investigator, renders them inappropriate for participation in this study * Excluded at the Principal Investigator's discretion

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Conditions

The condition(s) this trial relates to.

Fever

As listed by the trial registrant

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

Fever Healthy

Contacts and locations

Locations

  • Children's Hospital of Orange County

    Orange, California, 92868, United States

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Other studies related to the condition(s) this trial covers.