Trial Outcomes & Findings for Clinical Performance of Masimo INVSENSOR00048 (DALI0001) (NCT NCT06922461)
NCT ID: NCT06922461
Last Updated: 2026-08-25
Results Overview
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 .
TERMINATED
4 participants
Approximately 90 minutes
2026-08-25
Participant Flow
Participant milestones
| Measure |
INVSENSOR00048
All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements
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
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|---|---|
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Overall Study
STARTED
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4
|
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Overall Study
COMPLETED
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4
|
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Overall Study
NOT COMPLETED
|
0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Performance of Masimo INVSENSOR00048 (DALI0001)
Baseline characteristics by cohort
| Measure |
INVSENSOR00048
n=4 Participants
All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements
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
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
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1 Participants
n=31 Participants
|
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Age, Categorical
>=65 years
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3 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
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2 Participants
n=31 Participants
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PRIMARY outcome
Timeframe: Approximately 90 minutesPopulation: 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
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 .
Outcome measures
| Measure |
INVSENSOR00048
n=1 Participants
All subjects are enrolled into the test group and are fitted with the non-invasive investigational sensor for body temperature measurements
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
Clinical Bias
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0.18 Degrees Celsius
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|
Primary Outcome
Limits of Agreement
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0.80 Degrees Celsius
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Adverse Events
INVSENSOR00048
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place