Trial Outcomes & Findings for Clinical Performance of Masimo Rad-GT (NCT NCT05779397)

Last Updated: 2023-07-25

Results Overview

The accuracy of the Masimo Rad-GT sensor will be determined by calculating the clinical bias (Δcb), limits of agreement (LA), and repeatability (σr). The temperature measurements from Masimo Rad-GT will be compared to the reference temperature measurements (Degrees Celsius).

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

1-3 hours

Results posted on

2023-07-25

Participant Flow

Of the 68 enrolled participants, 68 completed the study.

Participant milestones

Participant milestones
Measure	Rad-GT All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device
Overall Study STARTED	68
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Performance of Masimo Rad-GT

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rad-GT n=68 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	68 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	22 Participants n=93 Participants
Sex: Female, Male Male	46 Participants n=93 Participants
Race/Ethnicity, Customized Ethnicity · Caucasian	32 Participants n=93 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic	5 Participants n=93 Participants
Race/Ethnicity, Customized Ethnicity · Asian or Pacific Islander	23 Participants n=93 Participants
Race/Ethnicity, Customized Ethnicity · Other	6 Participants n=93 Participants
Race/Ethnicity, Customized Ethnicity · More than one	2 Participants n=93 Participants
Region of Enrollment United States	68 Participants n=93 Participants

PRIMARY outcome

Timeframe: 1-3 hours

Population: Data for 7 subjects was excluded as they did not complete at least one full one round of measurements. Data for 37 subjects was excluded as the data suggested existence of external conditions that interfere with RCT (reference clinical thermometer) or Rad-GT measurements.

Outcome measures

Outcome measures
Measure	Rad-GT n=24 Participants All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT Masimo RAD-GT: Non-contact infrared thermometry device
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) Clinical Bias	-0.24 Degrees Celsius
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) Limits of Agreement	0.85 Degrees Celsius
Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius) Repeatability	0.04 Degrees Celsius

Adverse Events

Rad-GT

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

Ahmed Alghazi

Masimo Corporation

Phone: 949-297-7000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place