NCT02723890

The Efficacy and Safety of Using the Novel Tyto Device

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Rabin Medical Center · Academic / Other
• Sex: All
• Age: 2 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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)

Conditions

• Pharyngitis
• Respiratory Diseases
• Cardiac Diseases
• Ear Infection

Interventions

Type	Name	Description
DEVICE	Tyto Device

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-01-01
• Completion: 2018-04-01
• First posted: 2016-03-31
• Last updated: 2018-04-24

Locations

1 site across 1 country: Israel