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System/Device name: Otoscopic recording and clinical data telemedicine software supporting its transmission and analysis.
Characteristics of the medical device:
The device is applied to an iPhone with a CE mark also from a CE-marked optical unit and the system operator, a consists of software under investigation.
The detailed operation is in the user guide in Hungarian included. The device makes a video recording of the external ear canal and about the tympanic membrane, and it records clinical data (symptoms, complaints).
The telephone application sends the data through the system to a doctor, who, by analyzing them, makes a diagnosis and provides therapy.
The study is a prospective, single-arm study. The specialist treating the real patient (called doctor 2) does not see or know the diagnosis and the therapy from the telemedicine system, or the recommendation from the telemedicine The diagnosis and therapeutic treatment established by the two methods are evaluated by an independent specialist and decides whether the primary diagnosis and therapeutic treatment are the same or not in the telemedicine system.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| telemedicine arm | Experimental | A recording of the ear of each patient with an ear problem was taken with the device, and then they were diagnosed and prescribed therapy in the traditional way. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| telemedicine | Device | Recording of the ear of each patient with an ear problem |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist. | The primary objectives of the study is: number of matching cases, measured with the similarity and matching of International Classification of Diseases (ICD) codes. | 1 day |
| Comparison of therapy | Matching or similarity of prescribed therapy, e.g. same family of antibiotics , or the type of active substance. The match based on Anatomical Therapeutic Chemical (ATC) Classification | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Otorhinolaryngology and Head and Neck Surgery Clinic | Szeged | Csongrád megye | 6720 | Hungary |
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| ID | Term |
|---|---|
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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