Clinical Performance of Masimo INVSENSOR00048

NCT06289556 | Terminated Results

• 1 other identifier: TEMP0001
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.

Conditions

Fever; Healthy

Outcome Measures

Primary Outcomes (1)

• Clinical Performance of Masimo INVSENSOR00048

  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 .

  Approximately 90 minutes

Study Arms (1)

INVSENSOR00048

EXPERIMENTAL

All subjects are enrolled into this arm and will have temperature measurements obtained.

Device: Masimo INVSENSOR00048

Interventions

Masimo INVSENSOR00048 DEVICE

Masimo INVSENSOR00048 will be used to collect temperature measurements.

INVSENSOR00048

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Afebrile subjects of all ages, or febrile subjects of all ages who meet the following criteria for screening temperature:
• sublingual temperature ≥ 37.5°C (99.5°F),
• rectal temperature ≥ 38.0°C (100.4°F),
• or axillary temperature ≥ 37.2°C (99.0°F)
• If subject is \< 18 years old, parents or legally authorized representatives (LAR) have provided informed consent and have signed all necessary related documents

You may not qualify if:

• Subjects with medical conditions such as inflammation at the measuring site or taking medications e.g. barbiturates, thyroid preparations, antipsychotics, or immunization within prior 7 days, which might skew clinical accuracy validation results such as, per the investigator's judgement
• Subjects unable to provide informed consent or assent, as appropriate
• Subjects with conditions at or around site of sensor placement or skin abnormalities affecting the sensor placement area such as psoriasis, eczema, angioma, scar tissue, burn, fungal infection, substantial skin breakdown that would prevent monitoring of physiological parameters during the study
• Subjects with known allergies to adhesive material used in medical equipment
• Subjects with medical conditions which, in the judgment of the investigator, renders them inappropriate for participation in this study
• Excluded at the Principal Investigator's discretion

Sponsors & Collaborators

• Masimo Corporation: lead

Study Sites (1)

Children's Hospital of Orange County

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Fever

Condition Hierarchy (Ancestors)

Body Temperature Changes; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Chelsea Frank
• Organization: Masimo Corporation

clinicalresearchdept@masimo.com

949-297-7000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2024
• First Posted: March 4, 2024
• Study Start: January 23, 2024
• Primary Completion: May 19, 2025
• Study Completion: May 19, 2025
• Last Updated: August 25, 2026
• Results First Posted: August 25, 2026

Record last verified: 2026-07

Locations

US (1)