Clinical trial NCT06781164: Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases
Official title: Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ear Infection
Telemedicine
Lead sponsor: Szeged University
Sponsor class: OTHER
Collaborators: name: University of Szeged, Hungary
First posted: 2025-01-17
Enrollment: 103
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist.
timeFrame: 1 day
measure: Comparison of therapy
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Szeged
country: Hungary
facility: Otorhinolaryngology and Head and Neck Surgery Clinic
state: Csongrád
Study officials:
References: