Status:
UNKNOWN
Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
Lead Sponsor:
Tyto Care Ltd
Conditions:
Body Temperature Measurement
Eligibility:
All Genders
Phase:
NA
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 co...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
January 24 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 24 2018
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03452020
Start Date
January 24 2018
End Date
June 24 2018
Last Update
March 2 2018
Active Locations (1)
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1
Schneider Children's Medical Center of Israel
Petah Tikva, Israel