An interventional study of Masimo INVSENSOR00048 in Fever and Healthy, sponsored by Masimo Corporation. Terminated at 1 site in United States. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Masimo Corporation (part of Danaher Corporation) · Interventional and Other
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
438 studies on the registry are indexed under Fever; 55 are open to participants now.
This study's enrollment of 180 is above the median of 123 across 271 interventional studies indexed under Fever.
Browse Fever studies →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.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All subjects are enrolled into this arm and will have temperature measurements obtained.
Device: Masimo INVSENSOR00048
Masimo INVSENSOR00048 will be used to collect temperature measurements.
Clinical Performance of Masimo INVSENSOR00048
The outcome measure is 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 INVSENSOR00048 and reference thermometer in degrees celsius. 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 | 180 |
| Completed | 109 |
| Not completed | 71 |
| Withdrew: Withdrawal by subject | 3 |
| Withdrew: Data transfer failure | 12 |
| Withdrew: Met data exclusion criteria | 56 |
The outcome measure is 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 INVSENSOR00048 and reference thermometer in degrees celsius. 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 | 0.19 |
| Limits of Agreement | 0.76 |
Collected over 1-5 hours. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| INVSENSOR00048 | 0/180 (0%) | 0/180 (0%) | 1/180 (0.6%) |
| Event | INVSENSOR00048 |
|---|---|
| Itchiness and redness at device placement siteInjury, poisoning and procedural complications | 1/180 |
| Age, Categorical(Participants) | INVSENSOR00048 |
|---|---|
| <=18 years | 109 |
| Between 18 and 65 years | 0 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | INVSENSOR00048 |
|---|---|
| Female | 71 |
| Male | 38 |
| Race (NIH/OMB)(Participants) | INVSENSOR00048 |
|---|---|
| American Indian or Alaska Native | 1 |
| Asian | 10 |
| Native Hawaiian or Other Pacific Islander | 2 |
| Black or African American | 4 |
| White | 66 |
| More than one race | 5 |
| Unknown or Not Reported | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
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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