NCT03452020

Evaluation of the Tyto Thermometer When Used in Clinical Care Setting

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (estimated)
• Sponsor: Tyto Care Ltd · Industry
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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

Type	Name	Description
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

Timeline

• Start date: 2018-01-24
• Primary completion: 2018-06-24
• Completion: 2018-06-24
• First posted: 2018-03-02
• Last updated: 2018-03-02

Locations

1 site across 1 country: Israel