Clinical Performance of Masimo INVSENSO… | Clinical Trial

Key information

Conditions

Temperature

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Febrile subjects aged 18 years and older who meet the following criteria for screening temperature:

sublingual temperature ≥ 37.5°C (99.5°F),
or axillary temperature ≥ 37.2°C (99.0°F)

Exclusion criteria

Subjects with medical conditions such as inflammation at the measuring site or taking medications which might skew clinical accuracy validation results (e.g. barbiturates, thyroid preparations, antipsychotics or immunization within prior 7 days) or per the investigator's judgement
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

Treatment and study plan

INVSENSOR00048

Device

Noninvasive sensor will be attached to the subjects' skin with a medical grade biodegradable /adhesive, approximately 2 inches below the left clavicle to measure temperature

Primary outcomes

Primary Outcome

Time frame: Approximately 90 minutes

The determination of the Masimo INVSENSOR00048 temperature performance by comparing the Clinical Bias and Limits of Agreement (LOA) between the corresponding adjustment mode temperature of the device under test (DUT) and reference thermometer. Clincal Bias is defined as mean difference between output temperatires of a clinical thermometer and a reference clinical thermometer for the intended reference body site with specified limitis of agreement when measured from selected group of subjects . Limits of agreement is defined as the magnitude of a potential disagreement between outputs of two clinical thermometers equal to double the standard deviation of output temperate differences when used on the same human subject .

Interested in participating?

Terminated

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Sponsors and collaborators

Lead sponsor

Masimo Corporation

Industry

Registry information

Official study title

Clinical Performance of Masimo INVSENSOR00048

Important dates

Study start: 2025
Primary completion: 2025
Study completion: 2025
First posted: Apr 10, 2025
Registry last updated: Aug 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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