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

NCT ID: NCT06781164

Last Updated: 2025-01-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2023-05-31

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.

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.

Conditions

Ear Infection; Telemedicine

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

telemedicine

Intervention Type: DEVICE

Recording of the ear of each patient with an ear problem

Interventions

telemedicine

Recording of the ear of each patient with an ear problem

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Szeged, Hungary

UNKNOWN

Sponsor Role: collaborator

Szeged University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Otorhinolaryngology and Head and Neck Surgery Clinic

Szeged, Csongrád megye, Hungary

Countries

Hungary

Other Identifiers

University of Szeged

Identifier Type: -

Identifier Source: org_study_id