Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

Not Applicable

• Conditions: Body Temperature Measurement
• Interventions: Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer

• Registration Number: NCT03452020
• Lead Sponsor: Tyto Care Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-01-24
• Status Verified: 2018-02
• Study First Submitted: 2018-02-14
• Study First Submitted QC: 2018-03-01
• Last Update Submitted: 2018-03-01
• Study First Posted: 2018-03-02
• Last Update Posted: 2018-03-02
• Primary Completion: 2018-06-24
• Study Completion: 2018-06-24

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tyto Thermometer, SoC Thermometer, Predicate IR Th	Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer	All the study participants undergo temperature measurements with: 1. Tyto Thermometer 2. Standard of Care thermometer 3. Predicate IR thermometer

Primary Outcome Measures

Name	Time	Method
Body temperature measurement	a period of no more than 12 minutes

Trial Locations

Locations (1)

Schneider Children's Medical Center of Israel; 🇮🇱 Petah Tikva, Israel