Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

Patients who present to the Emergency Department will be evaluated for eligibility to the study. Those meeting all the inclusion criteria and none of the exclusion criteria will undergo an informed consent process and will sign a written consent. Within each age group both afebrile and febrile patients will be represented.

The patients will be divided into 3 study groups by age:

Group 1: up to 1 year Group 2: 1 to 5 years Group 3: older than 5 years

The following temperature measurements will be taken:

1. Three temperature measurements using the Tyto thermometer
2. Temperature measurement using the standard of care
3. Three temperature measurements using the predicate device

Study Overview

• Status: Unknown
• Conditions: Body Temperature Measurement
• Intervention / Treatment: Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer

• Study Type: Interventional
• Enrollment (Anticipated): 124
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Petah Tikva, Israel
    • Recruiting
    • Schneider Children's Medical Center of Israel
    • Contact: Assaf Sharabi, MD; Phone Number: 972544747245; Email: AssafSh@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female, of any age
2. Subject or Parent/Guardian: able to communicate with study personnel;
3. Subject or Parent/Guardian: able to understand the nature of the study and provide written informed consent
4. Subject or Parent/Guardian willing to comply with study procedures

Exclusion Criteria:

1. Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
2. Subject or legal guardian unwilling to sign informed consent form
3. Those with signs or recent history of inflammation or infection of the forehead or at the Reference Clinical Test site (site of temperature measurement in any one of the devices used).
4. Subjects currently using cooling blankets, ice on their forehead or fans.
5. Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
6. Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
7. Subjects with documented illicit drug use or alcoholic intoxication
8. Those participating in a clinical trial of an investigational medicinal product
9. Carriers of multi drug resistant bacteria
10. Pregnancy
11. CTAS score of 1-2

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Tyto Thermometer, SoC Thermometer, Predicate IR Th; All the study participants undergo temperature measurements with: Tyto Thermometer; Standard of Care thermometer; Predicate IR thermometer	Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer; Temperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Body temperature measurement	a period of no more than 12 minutes

Collaborators and Investigators

• Sponsor: Tyto Care Ltd
• Investigators: Principal Investigator: Yehezkel Waisman, Prof., Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2018
• Primary Completion (Anticipated): June 24, 2018
• Study Completion (Anticipated): June 24, 2018

Study Registration Dates

• First Submitted: February 14, 2018
• First Submitted That Met QC Criteria: March 1, 2018
• First Posted (Actual): March 2, 2018

Study Record Updates

• Last Update Posted (Actual): March 2, 2018
• Last Update Submitted That Met QC Criteria: March 1, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 790-00038

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No