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The Efficacy and Safety of Using the Novel Tyto Device

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ClinicalTrials.gov Identifier: NCT02723890
Recruitment Status : Completed
First Posted : March 31, 2016
Last Update Posted : April 24, 2018
Sponsor:
Information provided by (Responsible Party):
waisman yehezkel, Rabin Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Pharyngitis Respiratory Diseases Cardiac Diseases Ear Infection Device: Tyto Device Not Applicable

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)


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 136 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients who present to the Emergency department and are categorized between 2-5 on the Canadian Triage & Acuity Scale (CTAS) scoring scale.

Exclusion Criteria:

  • CTAS 1.
  • Pregnant adolescent.
  • Multi-drug resistant carriers.
  • Intellectual disability disorders.
  • Unsigned informed consent.

    • Patients with CTAS score of 2-3, will be first addressed by a physician to ascertain their eligibility to be enrolled to the study.

Information from the National Library of Medicine

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


Locations
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Israel
Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel
Petach Tikva, Israel, 4920235
Sponsors and Collaborators
Rabin Medical Center

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Responsible Party: waisman yehezkel, Associate Professor, MD, Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02723890     History of Changes
Other Study ID Numbers: RMC-15-0266
First Posted: March 31, 2016    Key Record Dates
Last Update Posted: April 24, 2018
Last Verified: April 2018

Additional relevant MeSH terms:
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Respiration Disorders
Respiratory Tract Diseases
Heart Diseases
Pharyngitis
Otitis
Cardiovascular Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ear Diseases