← Back to all trials
Terminated
NCT06922461
Clinical Performance of Masimo INVSENSOR00048 (DALI0001)
Conditions: Temperature
Sex: All
Ages: 18 Years – 100 Years
Healthy volunteers: No
Enrollment: 4
Sponsor: Masimo Corporation
Location: UC Davis Medical Center Sacramento California
Summary
This clinical study is to validate temperature performance of the noninvasive Masimo INVSENSOR00048.
Eligibility Criteria
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT06922461). StuddyBuddy aggregates publicly available trial information.