The Efficacy and Safety of Using the Novel Tyto Device
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02723890|
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : April 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Pharyngitis Respiratory Diseases Cardiac Diseases Ear Infection||Device: Tyto Device||Not Applicable|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||136 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||July 2016|
|Actual Primary Completion Date :||January 2017|
|Actual Study Completion Date :||April 2018|
Experimental: Tyto Device
examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis.
Device: Tyto Device
- The concordance of diagnosis and physical findings using the Tyto device on the heart, lung ear and throat as compared to standard physical examination (normal heart and lung sounds, arrhythmia, crackles, normal appearance of ear and throat or otherwise) [ Time Frame: up to 6 hrs ]during the visit to the emergency department.
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 [ Time Frame: up to 6 hrs ]during the visit to the emergency department.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02723890
|Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel|
|Petach Tikva, Israel, 4920235|