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Completed

NCT Number: NCT06781164

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

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.

Completed

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Key information

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Otorhinolaryngology and Head and Neck Surgery Clinic

Szeged, Csongrád megye, 6720, Hungary

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telemedicine

Device

Recording of the ear of each patient with an ear problem

Primary outcomes

  1. Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist.

    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.

  2. Comparison of therapy

    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

Sponsors and collaborators

Lead sponsor

Szeged University

Other

Registry information

Acronym: TMED_FOG_001

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Jan 17, 2025
Registry last updated
Jan 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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