Evaluation of the Tyto Thermometer When Used in Clinical Care Setting
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|ClinicalTrials.gov Identifier: NCT03452020|
Recruitment Status : Unknown
Verified February 2018 by Tyto Care Ltd.
Recruitment status was: Recruiting
First Posted : March 2, 2018
Last Update Posted : March 2, 2018
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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:
- Three temperature measurements using the Tyto thermometer
- Temperature measurement using the standard of care
- Three temperature measurements using the predicate device
|Condition or disease||Intervention/treatment||Phase|
|Body Temperature Measurement||Device: Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||124 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of the Tyto Thermometer When Used in Clinical Care Setting|
|Actual Study Start Date :||January 24, 2018|
|Estimated Primary Completion Date :||June 24, 2018|
|Estimated Study Completion Date :||June 24, 2018|
Tyto Thermometer, SoC Thermometer, Predicate IR Th
All the study participants undergo temperature measurements with:
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
- Body temperature measurement [ Time Frame: a period of no more than 12 minutes ]
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|Ages Eligible for Study:||Child, Adult, Older Adult|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
- 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
- CTAS score of 1-2
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03452020
|Contact: Stella Raizelman Perry, MScfirstname.lastname@example.org|
|Contact: Ofer Tzadik, Engemail@example.com|
|Schneider Children's Medical Center of Israel||Recruiting|
|Petah Tikva, Israel|
|Contact: Assaf Sharabi, MD 972544747245 AssafSh@clalit.org.il|
|Principal Investigator:||Yehezkel Waisman, Prof.||Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel|
|Responsible Party:||Tyto Care Ltd|
|Other Study ID Numbers:||
|First Posted:||March 2, 2018 Key Record Dates|
|Last Update Posted:||March 2, 2018|
|Last Verified:||February 2018|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
|Product Manufactured in and Exported from the U.S.:||No|