Trial Outcomes & Findings for Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts (NCT NCT05787782)

Last Updated: 2025-10-31

Results Overview

Masimo INVSENSOR00063 temperature measurements will be compared to reference temperature measurements. Accuracy of Masimo INVSENSOR00063 will be measured using clinical bias, limits of agreement and repeatability.

Recruitment status

COMPLETED

Study phase

Target enrollment

60 participants

Primary outcome timeframe

About 15-30 minutes

Results posted on

2025-10-31

Participant Flow

Participant milestones

Participant milestones
Measure	Masimo INVSENSOR00063 All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature
Overall Study STARTED	60
Overall Study COMPLETED	60
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Masimo INVSENSOR00063 n=60 Participants All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature
Age, Categorical <=18 years	31 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	39 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	38 Participants n=5 Participants
Race (NIH/OMB) More than one race	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: About 15-30 minutes

Population: Data for 1 subject was excluded as they did not complete one round of measurements. Data for 1 subject was excluded as the data suggested existence of external conditions that interefere with RCT (reference clinical thermometer) or Masimo INVSENSOR00063 measurements.

Outcome measures

Outcome measures
Measure	Masimo INVSENSOR00063 n=58 Participants All subjects are enrolled into this arm and will have temperature measurements obtained. Masimo INVSENSOR00063: Masimo INVSENSOR00063 will be used to measure temperature
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 Clinical Bias	-0.24 Degrees Celsius
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 Limits of Agreement	0.85 Degrees Celsius
Accuracy of Temperature Measurements Using Masimo INVSENSOR00063 Repeatability	0.05 Degrees Celsius

Adverse Events

Masimo INVSENSOR00063

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Chelsea Frank

Masimo

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60