Clinical Performance of Masimo INVSENSOR00048 (DALI0001)

NCT06922461 | Terminated Results

• 1 other identifier: DALI0001
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.

Conditions

Temperature

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  The 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 device under test (DUT) and reference thermometer. 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 the test group and are fitted with the non-invasive investigational sensor for body temperature measurements

Device: INVSENSOR00048

Interventions

INVSENSOR00048 DEVICE

Noninvasive sensor will be attached to the subjects' skin with a medical grade biodegradable /adhesive, approximately 2 inches below the left clavicle to measure temperature

INVSENSOR00048

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Febrile subjects aged 18 years and older who meet the following criteria for screening temperature:
• sublingual temperature ≥ 37.5°C (99.5°F),
• or axillary temperature ≥ 37.2°C (99.0°F)

You may not qualify if:

• Subjects with medical conditions such as inflammation at the measuring site or taking medications which might skew clinical accuracy validation results (e.g. barbiturates, thyroid preparations, antipsychotics or immunization within prior 7 days) or per the investigator's judgement
• 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)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

Limitations and Caveats

The study was terminated early and the sample size was insufficient to statistically compare data collected to the reference values. Hence, the clinical performance of the Masimo INVSENSOR00048 could not be computed.

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: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: May 2, 2025
• Primary Completion: May 22, 2025
• Study Completion: May 22, 2025
• Last Updated: August 25, 2026
• Results First Posted: August 25, 2026

Record last verified: 2026-07

Locations

US (1)