Clinical Performance of Masimo INVSENSOR00048

Masimo

Status

Terminated

Conditions

Fever

Healthy

Treatments

Device: Masimo INVSENSOR00048

Study type

Interventional

Funder types

Industry

Identifiers

TEMP0001

Details and patient eligibility

About

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

Enrollment

180 patients

Sex

All

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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