An interventional study of INVSENSOR00048 in Temperature, sponsored by Masimo Corporation. Terminated at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Masimo Corporation (part of Danaher Corporation) · Interventional and Other
This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Masimo Corporation is the lead sponsor of 105 studies on the registry; 1 is open to participants now.
Of its 79 completed or terminated interventional studies of FDA-regulated products, 66 (84%) have results posted.
First submitted before Masimo Corporation became part of Danaher Corporation.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Febrile subjects aged 18 years and older who meet the following criteria for screening temperature:
Exclusion Criteria:
All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements
Device: INVSENSOR00048
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 Outcome
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 .
Time frame: Approximately 90 minutes
| Milestone | INVSENSOR00048 |
|---|---|
| Started | 4 |
| Completed | 4 |
| Not completed | 0 |
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 .
| Degrees Celsius | INVSENSOR00048 |
|---|---|
| Clinical Bias | 0.18 |
| Limits of Agreement | 0.80 |
Collected over At a single visit for approximately 1 to 5 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INVSENSOR00048 | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| Age, Categorical(Participants) | INVSENSOR00048 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 1 |
| >=65 years | 3 |
| Sex: Female, Male(Participants) | INVSENSOR00048 |
|---|---|
| Female | 3 |
| Male | 1 |
| Race (NIH/OMB)(Participants) | INVSENSOR00048 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 2 |
| More than one race | 0 |
| Unknown or Not Reported | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from May 2025 to primary completion in May 2025, 0 months.
Results were first posted in Aug 2026, 1 year 3 months after primary completion.
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This study is terminated, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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