Otorhinolaryngology and Head and Neck Surgery Clinic
Szeged, Csongrád megye, 6720, Hungary
NCT Number: NCT06781164
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.
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Notify Me6 year and older
All sexes
Interventional
Not applicable
Szeged, Csongrád megye, 6720, Hungary
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Recording of the ear of each patient with an ear problem
Time frame: 1 day
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
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
Szeged University
Other
Acronym: TMED_FOG_001
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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