Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,622
- 试验地点
- 3
- 主要终点
- Determination of the sensitivity and specificity
研究概览
简要总结
Purpose: To evaluate the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases using the Ivenus application (within C0-C2 according to CEAP).
Materials and methods: Patients who applied to several phlebology clinics for an initial consultation are consistently included in a multicenter prospective study. At the appointment, a doctor with at least 5 years of experience takes photographs of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP, without showing the results to the surgeon (blinding). Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.
The object of the study is a photograph of a certain area of the lower limb.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •C0-C2 CEAP clinical class;
- •Signed consent to take part in investigation.
排除标准
- •C3-C6 CEAP clinical class;
- •Skin diseases of the lower extremities;
- •Immobilization.
结局指标
主要结局
Determination of the sensitivity and specificity
时间窗: 1 day
Determination of the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases according to the CEAP classification using the IVENUS application (within C0-C2 classes).
次要结局
- Number of participants with complications(1 day)
研究者
Denis Borsuk
Director
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia