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The Efficacy and Safety of Using the Novel Tyto Device

Pharyngitis Clinical Trial

Official title:
The Efficacy and Safety of Using the Novel Tyto Device for Remote Physical Examination by a Physician as Compared to a Standard Medical Physical Examination

Clinical Trial Summary

To investigate the efficacy and safety of using the novel Tyto device for remote physical examination by co-investigators as compared to a standard medical physical examination by physicians.

Clinical Trial Description

A single center, prospective, qualitative study. Patients referred to the emergency department will be triaged according to The Canadian Triage & Acuity Scale (CTAS).

Patients presenting with complaints suitable for examination with the Tyto device (ear/throat/respiratory/cardiac complaints) and meeting the inclusion criteria will be informed and asked for consent. Patients participating in the study will be referred to a room dedicated for the purpose.

A minimum of a hundred volunteer patients will be selected and enrolled for a preliminary Pilot Study. Final study design and its extent will be determined accordingly.

Physical examinations using the Tyto device will be performed by the co-investigators, and sent online to the principle investigator for remote analysis.

The emergency department physician will examine the patient using conventional examination instruments (i.e. stethoscope, otoscope).

The data collected will be recorded on predetermined case report form (CRF), timed, stored and analyzed by the principle and co-investigators. The findings of the co-investigators' examination will be compared to the conventional examination instruments used by the emergency department physician.

Results will be checked and compared categorically (0-inconclusive; 1-normal; 2-pathological findings) ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02723890
Study type Interventional
Source Rabin Medical Center
Contact
Status Completed
Phase N/A
Start date July 2016
Completion date April 2018
View Details
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