Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018

Completed · Not applicable

Conditions studied: Febrile Illness

In brief

The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to ISO 80601-2-56:2017 + A1 2018.

Key facts

Study ID

NCT06056011

Run by

Baxter Healthcare Corporation

People needed

373

Starts

2024-02-19

Expected to finish

2025-03-18

Last updated by the study team

2026-03-11

Who can join

Age: 0 and older, up to 99. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study:
• Subjects that are minors must provide assent to the clinical site's policy (if approved by Baxter) and/or the study sponsor's policy to participate in the study.
• Subject or the legally authorized representative (LAR) must sign the informed consent form in order for the subject to participate.
• Subject must be willing and able to comply with the study procedures.
• Age: normal weight (full-term) newborn to adult
• The study subject is in ambient temperature for at least 20 minutes prior to participating.
• The study subject is able to have their temperature taken for up to six minutes for multiple rounds of temperatures per anatomical site.
• The study subject is not physically or emotionally agitated/uncooperative.
• The study subject or legal guardian speaks/understands fluent English.

You may not qualify if…

• Study subjects (person who is having their temperature taken) are excluded if they meet any of the below criteria. Any subject that withdraws from the study will be replaced.
• The study subject has anatomical abnormalities that would affect temperature.
• The study subject has any known contraindication to oral, axillary, or rectal temperature measurements.
• The subject is not alert or unable to follow simple commands such as closing one's mouth completely around the probe if an oral reference temperature is being taken.
• The study subject has consumed food or drink, or smoked, within the last 20 minutes. The subject may be included if they wait 20 minutes prior to taking oral temperature.
• The study subject has engaged in strenuous or semi-strenuous activity within the last twenty minutes (i.e., running, weightlifting, etc.).
• Subject has taken antipyretics (Aspirin, acetaminophen, ibuprofen) in the preceding 120 minutes.
• Subjects has medical conditions such as inflammation at the MEASURING SITE (Barbiturates, thyroid preparations, antipsychotics, recent immunizations).
• Neutropenic immunocompromised patients, in whom rectal manipulation may seed the blood with bacteria.
• Note: The study subject will be excluded if the reference temperature does not stabilize after the 3 -5 minute monitoring time.

Where it is running

• Forest Lane Pediatrics — Dallas, Texas, United States
• First Georgia Physicians Group — Fayetteville, Georgia, United States
• Mankato Clinic — Mankato, Minnesota, United States
• John R. Oishei Children's Hospital — Buffalo, New York, United States
• Medical University of South Carolina — Charleston, South Carolina, United States

Full record on ClinicalTrials.gov

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