NCT02723890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
136

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2016

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 24, 2018

Status Verified

April 1, 2018

Enrollment Period

6 months

First QC Date

March 1, 2016

Last Update Submit

April 22, 2018

Conditions

PharyngitisRespiratory DiseasesCardiac DiseasesEar Infection

Outcome Measures

Primary Outcomes (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)

    during the visit to the emergency department.

    up to 6 hrs

Secondary Outcomes (1)

  • Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

    up to 6 hrs

Study Arms (1)

Tyto Device

EXPERIMENTAL

examination with Tyto device carried out by a nurse and sent online to the principle and co-investigators for remote analysis.

Device: Tyto Device

Interventions

Tyto DeviceDEVICE
Tyto Device

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel

Petah Tikva, 4920235, Israel

Location

MeSH Terms

Conditions

PharyngitisRespiratory Tract DiseasesHeart DiseasesOtitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesOtorhinolaryngologic DiseasesCardiovascular DiseasesEar Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, MD

Study Record Dates

First Submitted

March 1, 2016

First Posted

March 31, 2016

Study Start

July 1, 2016

Primary Completion

January 1, 2017

Study Completion

April 1, 2018

Last Updated

April 24, 2018

Record last verified: 2018-04

Locations

IL(1)