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Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
Sponsor:
Information provided by (Responsible Party):
Tyto Care Ltd

Study Description
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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

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Arms and Interventions
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Arm Intervention/treatment
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
 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


Outcome Measures
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Primary Outcome Measures :
  1. Body temperature measurement [ Time Frame: a period of no more than 12 minutes ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Stella Raizelman Perry, MSc 972.72.221.0750 stellar@tytocare.com
Contact: Ofer Tzadik, Eng 972524761210 ofert@tytocare.com

Locations
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Israel
Schneider Children's Medical Center of Israel Recruiting
Petah Tikva, Israel
Contact: Assaf Sharabi, MD    972544747245    AssafSh@clalit.org.il   
Sponsors and Collaborators
Tyto Care Ltd
Investigators
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Principal Investigator: Yehezkel Waisman, Prof. Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel
More Information
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Responsible Party: Tyto Care Ltd
ClinicalTrials.gov Identifier: NCT03452020    
Other Study ID Numbers: 790-00038
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

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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