Status:
COMPLETED
Timmy3 Module Clinical Accuracy ISO 80601-2-56:2017 + A1 2018
Lead Sponsor:
Baxter Healthcare Corporation
Conditions:
Febrile Illness
Eligibility:
All Genders
1-99 years
Phase:
NA
Brief Summary
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.
Detailed Description
The purpose of this document is to validate the clinical accuracy of the TIMMY3 thermometry module, integrated into host device CVSM, according to 80601-2-56:2017 + A1 2018. This study is designed to...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 19 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2025
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT06056011
Start Date
February 19 2024
End Date
March 18 2025
Last Update
November 3 2025
Active Locations (5)
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1
First Georgia Physicians Group
Fayetteville, Georgia, United States, 30214
2
Mankato Clinic
Mankato, Minnesota, United States, 56001
3
John R. Oishei Children's Hospital
Buffalo, New York, United States, 14203
4
Medical University of South Carolina
Charleston, South Carolina, United States, 29425