NCT06781164

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 103 (actual)
• Sponsor: Szeged University · Academic / Other
• Sex: All
• Age: 6 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	telemedicine	Recording of the ear of each patient with an ear problem

Timeline

• Start date: 2020-04-01
• Primary completion: 2023-05-23
• Completion: 2023-05-31
• First posted: 2025-01-17
• Last updated: 2025-01-17

Locations

1 site across 1 country: Hungary