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Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

NCT03452020 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2018-03-02

No results posted yet for this 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

Conditions

  • Body Temperature Measurement

Interventions

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

Sponsors & Collaborators

  • Tyto Care Ltd

    lead INDUSTRY

Principal Investigators

  • Yehezkel Waisman, Prof. · Director, Department of Emergency Medicine, Schneider Children's Medical Center of Israel

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-24
Primary Completion
2018-06-24
Completion
2018-06-24

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03452020 on ClinicalTrials.gov