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

NCT06781164 | Completed

• 1 other identifier: University of Szeged
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Ear Infection; Telemedicine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

telemedicine arm

EXPERIMENTAL

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

Interventions

telemedicine DEVICE

Recording of the ear of each patient with an ear problem

telemedicine arm

Eligibility Criteria

• Age: 6 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Szeged University: lead
• University of Szeged, Hungary: collaborator

Study Sites (1)

Otorhinolaryngology and Head and Neck Surgery Clinic

Szeged, Csongrád megye, 6720, Hungary

Location

MeSH Terms

Conditions

Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2024
• First Posted: January 17, 2025
• Study Start: April 1, 2020
• Primary Completion: May 23, 2023
• Study Completion: May 31, 2023
• Last Updated: January 17, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (1)