TemperatureNCT06922461

Clinical Performance of Masimo INVSENSOR00048 (DALI0001)

A study testing INVSENSOR00048 in people with Temperature, run by Masimo Corporation at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048. Read more about this study

Who is it for?: Ages 18 to 100 years
Conditions the study is for: Temperature
What is being tested?: INVSENSOR00048
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: 2 May 2025to 22 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 18 to 100 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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)

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UC Davis Medical Center
Sacramento, California, 95817

Other trials in United States

About this study

Official title: Clinical Performance of Masimo INVSENSOR00048

This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.

Conditions: Temperature
Being tested: INVSENSOR00048

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

INVSENSOR00048Device
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

Study groups in NCT06922461
Study group	Role	What they receive
INVSENSOR00048	Experimental	All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements Receives: Device: INVSENSOR00048

What is being measured

The primary outcome is the main question the study is designed to answer.

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 .
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.

2 May 202522 May 2025

First posted10 Apr 2025
Study start2 May 2025
Primary completion22 May 2025
Study completion22 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 TemperatureStudies 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: Single group
Masking: None (open label)
Enrolment: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06922461
Sponsor's protocol ID: DALI0001
Status last verified: Jul 2026
First submitted: 3 Apr 2025
Last updated: 25 Aug 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Temperature trials

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: NCT06922461
Acronym / sponsor ID: DALI0001
Conditions: Temperature
Study type: Interventional
Recruitment status: TerminatedReason stopped: Sponsor decision
Enrolment: 4 participants (actual)
Lead sponsor: Masimo CorporationIndustry (pharma, biotech, devices)
Study start: 2 May 2025 (actual)
Primary completion: 22 May 2025 (actual)
Study completion: 22 May 2025 (actual)
First posted: 10 Apr 2025 (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.

This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
INVSENSOR00048	Experimental	Device: INVSENSOR00048All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements

Who may qualify

Ages: 18 to 100 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (5 listed)

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

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
INVSENSOR00048Noninvasive sensor will be attached to the subjects' skin with a medical grade biodegradable /adhesive, approximately 2 inches below the left clavicle to measure temperature	Device	INVSENSOR00048

Primary outcome

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 .

Results and safety

Results posted to the registry on 25 Aug 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
INVSENSOR00048	4	4

Primary outcome: Primary Outcome

Time frame: Approximately 90 minutes. Number. Unit: Degrees Celsius

Measure	INVSENSOR00048 n = 1
Clinical Bias	0.18
Limits of Agreement	0.80

Population analysed: The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the clinical performance of the Masimo INVSENSOR00048 could not be computed. Subjects were excluded from analysis due toa lack of a minimum of three (3) reference measurement groups , data that suggests a defective device or sensor , or data that suggests the existence of external conditions that interfere with DUT measurements or reference measurements

Adverse events

Time frame: At a single visit for approximately 1 to 5 hours. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
INVSENSOR00048	0 of 4 (0%)	0 of 4 (0%)	0 of 4

Limitations and caveats (from the sponsor): The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the clinical performance of the Masimo INVSENSOR00048 could not be computed.

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.

Related trials for Temperature

RecruitingObservational study
Diagnosis and Management of Inflammatory and Infectious Diseases
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Recruiting
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RecruitingObservational study
Host and Parasite Factors That Influence Susceptibility to Malaria Infection and Disease During Pregnancy and Early Childhood in Ouelessebougou and Bamako, Mali
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RecruitingObservational study
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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 INVSENSOR00048 in people with Temperature, 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 3 inclusion and 5 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?

Primary Outcome (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?

On the ClinicalTrials.gov record for NCT06922461.

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.