Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

Body Temperature Measurement Clinical Trial

Official title:

Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03452020
• Other study ID #: 790-00038
• Status: Recruiting
• Phase: N/A
• First received: February 14, 2018
• Last updated: March 1, 2018
• Start date: January 24, 2018
• Est. completion date: June 24, 2018

Study information

• Verified date: February 2018
• Source: Tyto Care Ltd
• Contact: Stella Raizelman Perry, MSc
• Phone: 972.72.221.0750
• Email: stellar[@]tytocare.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 124
• Est. completion date: June 24, 2018
• Est. primary completion date: June 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Body Temperature Measurement

Intervention

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

Locations

Country	Name	City	State
Israel	Schneider Children's Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Tyto Care Ltd

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body temperature measurement		a period of no more than 12 minutes