Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

NCT03452020 | Unknown

• 1 other identifier: 790-00038
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Conditions

Body Temperature Measurement

Outcome Measures

Primary Outcomes (1)

• Body temperature measurement

  a period of no more than 12 minutes

Study Arms (1)

Tyto Thermometer, SoC Thermometer, Predicate IR Th

OTHER

All the study participants undergo temperature measurements with: 1. Tyto Thermometer 2. Standard of Care thermometer 3. Predicate IR thermometer

Device: Temperature measurementsusing 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 DEVICE

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

Tyto Thermometer, SoC Thermometer, Predicate IR Th

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Cognitive impairment, history of dementia, psychiatric disorders, mental disorders or PDD.
• Subject or legal guardian unwilling to sign informed consent form
• 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).
• Subjects currently using cooling blankets, ice on their forehead or fans.
• Subjects receiving treatment with antipyretics, barbiturates, antipsychotics for the past 3 hours.
• Subjects receiving current systemic treatment with thyroid preparations, corticosteroids or underwent immunizations during the past 7 days.
• Subjects with documented illicit drug use or alcoholic intoxication
• Those participating in a clinical trial of an investigational medicinal product
• Carriers of multi drug resistant bacteria
• Pregnancy
• CTAS score of 1-2

Sponsors & Collaborators

• Tyto Care Ltd: lead

Study Sites (1)

Schneider Children's Medical Center of Israel

Petah Tikva, Israel

RECRUITING

Study Officials

• Yehezkel Waisman, Prof.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Stella Raizelman Perry, MSc

CONTACT

972.72.221.0750; stellar@tytocare.com

Ofer Tzadik, Eng

CONTACT

972524761210; ofert@tytocare.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2018
• First Posted: March 2, 2018
• Study Start: January 24, 2018
• Primary Completion: June 24, 2018
• Study Completion: June 24, 2018
• Last Updated: March 2, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)