Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

NCT ID: NCT03452020

Last Updated: 2018-03-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-24
• Study Completion Date: 2018-06-24

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

Conditions

Body Temperature Measurement

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Tyto Thermometer, SoC Thermometer, Predicate IR Th

All the study participants undergo temperature measurements with:

1. Tyto Thermometer

2. Standard of Care thermometer

3. Predicate IR thermometer

Group Type: OTHER

Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer

Intervention Type: DEVICE

Temperature measurements using the Tyto thermometer, the standard of care thermometer and the predicate thermometer

Interventions

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Tyto Care Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yehezkel Waisman, Prof.

Role: PRINCIPAL_INVESTIGATOR

Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel

Locations

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Stella Raizelman Perry, MSc

Role: CONTACT

stellar@tytocare.com

972.72.221.0750

Ofer Tzadik, Eng

Role: CONTACT

ofert@tytocare.com

972524761210

Facility Contacts

Assaf Sharabi, MD

Role: primary

AssafSh@clalit.org.il

972544747245

Other Identifiers

790-00038

Identifier Type: -

Identifier Source: org_study_id