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

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.

Study Overview

• Status: Completed
• Conditions: Telemedicine; Ear Infection
• Intervention / Treatment: Device: telemedicine

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.

• Study Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hungary
  • Csongrád
    • Szeged, Csongrád, Hungary, 6720
      • Otorhinolaryngology and Head and Neck Surgery Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: telemedicine arm; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	1 day

Collaborators and Investigators

• Sponsor: Szeged University
• Collaborators: University of Szeged, Hungary

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): May 23, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: December 26, 2024
• First Submitted That Met QC Criteria: January 13, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis
• Other Study ID Numbers: University of Szeged

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No