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
Verified date | April 2018 |
Source | Rabin Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 136 |
Est. completion date | April 2018 |
Est. primary completion date | January 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Israel | Dept. of Emergency Medicine, Schneider Children's Medical Center of Israel | Petach Tikva |
Lead Sponsor | Collaborator |
---|---|
Rabin Medical Center |
Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 | during the visit to the emergency department. | up to 6 hrs |
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