Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases (TMED_FOG_001)

University of Szeged (SZTE)

Status: Completed

Conditions: Ear Infection; Telemedicine

Treatments: Device: telemedicine

Study type: Interventional

Funder types: Other

Identifiers

NCT06781164

University of Szeged

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 103 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Signed informed consent form
• Patients with ear complaints (especially, but not exclusively, ear pain from the ear discharge, itching, cerumen accumulation,)
• The subject communicates well with the investigator and is able to understand the requirements of the test plan and to help with compliance.

Exclusion criteria

• Poor general condition
• Based on the investigator's decision, a condition that directly threatens life or a symptom that corresponds to these may indicate (e.g.: Liquor dripping, massive bleeding, etc.)
• Any disease that, in the investigator's opinion, endangers the patient's health and/or contraindicates performing the test
• The examiner finds that further participation is a disadvantage for the patient for any reason;
• the patient requests the suspension of his participation orally or in writing

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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103 participants in 1 patient group

telemedicine arm

Experimental group

Description:

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.

Treatment:

Device: telemedicine