An interventional study of telemedicine in Ear Infection and Telemedicine, sponsored by Szeged University. Completed at 1 site in Hungary. Open to participants aged 6 Years and older. Per ClinicalTrials.gov, last updated 2025-01-17.
Sponsored by Szeged University · Not applicable, Interventional, and Diagnostic
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.
80 studies on the registry are indexed under Otitis; 10 are open to participants now.
This study's enrollment of 103 is below the median of 183 across 54 interventional studies indexed under Otitis.
Browse Otitis studies →Szeged University is the lead sponsor of 56 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: telemedicine
Recording of the ear of each patient with an ear problem
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.
Time frame: 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
Time frame: 1 day
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Szeged University