FeverNCT06289556
Clinical Performance of Masimo INVSENSOR00048
A study testing Masimo INVSENSOR00048 in people with Fever and Healthy, run by Masimo Corporation at 1 site in United States.
Trial summary
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Masimo INVSENSOR00048
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jan 2024to 19 May 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital of Orange County
Orange, California, 92868
About this study
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
- Being tested
- Masimo INVSENSOR00048
- Medical subject headings
- Fever
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Masimo INVSENSOR00048Device
Masimo INVSENSOR00048 will be used to collect temperature measurements.
| Study group | Role | What they receive |
|---|---|---|
| INVSENSOR00048 | Experimental | All subjects are enrolled into this arm and will have temperature measurements obtained. Receives: Device: Masimo INVSENSOR00048 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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 .
Measured: Approximately 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start23 Jan 2024
- Primary completion19 May 2025
- Study completion19 May 2025
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masimo Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06289556
- Sponsor's protocol ID
- TEMP0001
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2024
- Last updated
- 25 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Performance of Masimo INVSENSOR00048
- ClinicalTrials.gov ID
- NCT06289556
- Acronym / sponsor ID
- TEMP0001
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Masimo CorporationIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2024 (actual)
- Primary completion
- 19 May 2025 (actual)
- Study completion
- 19 May 2025 (actual)
- First posted
- 4 Mar 2024 (actual)
- Results
- Posted 25 Aug 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| INVSENSOR00048 | Experimental | Device: Masimo INVSENSOR00048All subjects are enrolled into this arm and will have temperature measurements obtained. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Masimo INVSENSOR00048Masimo INVSENSOR00048 will be used to collect temperature measurements. | Device | INVSENSOR00048 |
Primary outcome
Clinical Performance of Masimo INVSENSOR00048
Time frame: Approximately 90 minutes
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 .
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Masimo INVSENSOR00048 in people with Fever and Healthy, run by Masimo Corporation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Aug 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Performance of Masimo INVSENSOR00048 (time frame: Approximately 90 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2026.