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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06056011
Other study ID # 60128116
Secondary ID
Status Enrolling by invitation
Phase N/A
First received
Last updated
Start date February 19, 2024
Est. completion date December 15, 2024

Study information

Verified date May 2024
Source Baxter Healthcare Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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 provide supporting documentation for the TIMMY3 module operating with SureTemp Plus algorithms. Testing will be performed with a production equivalent CVSM modified to use TIMMY3 (TIMMY3 investigational device), running the SureTemp Plus algorithms. The TIMMY3 module is intended to be integrated into additional Welch Allyn devices such as, but not limited to, the Connex Spot Monitor and Spot 4400. The process described below will be followed in accordance with the method called out in ISO 80601-2-56:2017 + A1:2018.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 420
Est. completion date December 15, 2024
Est. primary completion date November 15, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Day to 99 Years
Eligibility Inclusion Criteria: - Study subjects (person who is having their temperature taken) must meet the following criteria to participate in this study: - Subjects that are between 7 and 17 years of age must provide assent to participate in the study. - Subjects must be able to provide an informed consent or have legally authorized representative consent 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 Criteria: - 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 study subject or their legally authorized representative (LAR) refuses to allow the study subject to participate for any reason. - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Connex CSVM with Timmy3 module
Connex Vital Signs Monitor with the Timmy3 Investigational module

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Baxter Healthcare Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Validate the Clinical Accuracy of the Timmy3 thermometer algorithm All age groups in the oral, adult and pediatric axillary, and rectal temperature modes. Clinical accuracy will include measurement of clinical bias, with its limits of agreement, and clinical repeatability as defined by the ISO 80601-2-56:2017 + A1:2018. Up to 2 years
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