Examination of the Applicability and Performance of Otolaryngology Telemedicine, Telediagnostics in Establishing the Diagnosis and Therapy of Otolaryngology Diseases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Comparison of therapy
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: telemedicine (Device)
结局指标
主要结局
Comparison of therapy
时间窗: 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
Comparison of the diagnoses treatments made by remote diagnostics and an on-site specialist.
时间窗: 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.
次要结局
未报告次要终点