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Status unknownNCT03452020Updated Mar 2, 2018

Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

An interventional study of Temperature measurementsusing the Tyto thermometer, the standard of care thermometer and the predicate thermometer in Body Temperature Measurement, sponsored by Tyto Care Ltd. Status unknown at 1 site in Israel. Per ClinicalTrials.gov, last updated 2018-03-02.

Sponsored by Tyto Care Ltd · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Feb 2018), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
124
Allocation
Not applicable
Sex
All
01

Study 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
02

Conditions studied

  • Body Temperature Measurement
03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
124 participants (estimated)

Study arms

  • Other
    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

Interventions

  • DeviceTemperature 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

05

What researchers measure

Primary outcomes

  1. Body temperature measurement

    Time frame: a period of no more than 12 minutes

06

Study locations

1 of 1 sites recruiting
  • Schneider Children's Medical Center of Israel
    Petah Tikva, Israel
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03452020
Lead sponsor
Tyto Care Ltd
Responsible party
Sponsor
First posted
Mar 2, 2018
Start date
Jan 24, 2018
Primary completion
Jun 24, 2018 (estimated)
Completion
Jun 24, 2018 (estimated)
Last update
Mar 2, 2018

Study contacts

Stella Raizelman Perry, MSc
Contact
stellar@tytocare.com
972.72.221.0750
Ofer Tzadik, Eng
Contact
ofert@tytocare.com
972524761210
Yehezkel Waisman, Prof.
principal investigator · Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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