Clinical Performance of Masimo Rad-GT

NCT05779397 | Completed Results FDA Device

• 1 other identifier: CIP-1064
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The study is designed to validate the clinical performance of Masimo Rad-GT in the accuracy of temperature measurements.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Accuracy of Masimo Rad-GT Temperature Measurements (Degrees Celsius)

  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).

  1-3 hours

Study Arms (1)

Test Subject

EXPERIMENTAL

All subjects who are enrolled into the test group and participate in data collection receive the noninvasive Masimo RAD-GT

Device: Masimo RAD-GT

Interventions

Masimo RAD-GT DEVICE

Non-contact infrared thermometry device

Test Subject

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is 18 to 80 years of age.
• Subjects are able to read and communicate in English as well as understand the study and the risks involved.

You may not qualify if:

• Subject is pregnant or nursing.
• Subject has a known neurological and/or psychiatric disorder (e.g., schizophrenia, bipolar disorder, Multiple Sclerosis, Huntington's disease) that interferes with the subject's level of consciousness. \*
• Subject has any medical condition which in the judgment of the investigator and/or study staff, renders them ineligible for participation in this study or subject is deemed ineligible by the discretion of the investigator/study staff.
• (\* = Per study staff discretion)

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Masimo Corporation

Irvine, California, 92618, United States

Location

Related Links

• Validation of the Masimo INVSENSOR00063 in Febrile and Afebrile Subejcts
• Calibration and Validation of the Masimo Temperature Device in Febrile Patients

Results Point of Contact

• Title: Ahmed Alghazi
• Organization: Masimo Corporation

aalghazi@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 22, 2023
• Study Start: February 20, 2023
• Primary Completion: February 23, 2023
• Study Completion: February 23, 2023
• Last Updated: July 25, 2023
• Results First Posted: July 25, 2023

Record last verified: 2023-06

Locations

US (1)