Trial Outcomes & Findings for Clinical Performance of Masimo INVSENSOR00048 (NCT NCT06289556)
NCT ID: NCT06289556
Last Updated: 2026-08-25
Results Overview
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 .
TERMINATED
180 participants
Approximately 90 minutes
2026-08-25
Participant Flow
Participant milestones
| Measure |
INVSENSOR00048
All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00048: Masimo INVSENSOR00048 will be used to collect temperature measurements.
|
|---|---|
|
Overall Study
STARTED
|
180
|
|
Overall Study
COMPLETED
|
109
|
|
Overall Study
NOT COMPLETED
|
71
|
Reasons for withdrawal
| Measure |
INVSENSOR00048
All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00048: Masimo INVSENSOR00048 will be used to collect temperature measurements.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Data Transfer Failure
|
12
|
|
Overall Study
Met Data Exclusion Criteria
|
56
|
Baseline Characteristics
Clinical Performance of Masimo INVSENSOR00048
Baseline characteristics by cohort
| Measure |
INVSENSOR00048
n=109 Participants
All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00048: Masimo INVSENSOR00048 will be used to collect temperature measurements.
|
|---|---|
|
Age, Categorical
<=18 years
|
109 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
10 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
5 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Approximately 90 minutesThe 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 .
Outcome measures
| Measure |
INVSENSOR00048
n=109 Participants
All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00048: Masimo INVSENSOR00048 will be used to collect temperature measurements.
|
|---|---|
|
Clinical Performance of Masimo INVSENSOR00048
Clinical Bias
|
0.19 Degrees Celsius
|
|
Clinical Performance of Masimo INVSENSOR00048
Limits of Agreement
|
0.76 Degrees Celsius
|
Adverse Events
INVSENSOR00048
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
INVSENSOR00048
n=180 participants at risk
All subjects are enrolled into this arm and will have temperature measurements obtained.
Masimo INVSENSOR00048: Masimo INVSENSOR00048 will be used to collect temperature measurements.
|
|---|---|
|
Injury, poisoning and procedural complications
Itchiness and redness at device placement site
|
0.56%
1/180 • 1-5 hours
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place