Varicose Veins of Lower Limb Clinical Trial
— IVENUSOfficial title:
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
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.
Status | Recruiting |
Enrollment | 1530 |
Est. completion date | August 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - C0-C2 CEAP clinical class; - Signed consent to take part in investigation. Exclusion Criteria: - C3-C6 CEAP clinical class; - Skin diseases of the lower extremities; - Immobilization. |
Country | Name | City | State |
---|---|---|---|
Russian Federation | Azbuka zdoroviya ltd. | Ekaterinburg | |
Russian Federation | Vasculab ltd. | Ekaterinburg | |
Russian Federation | Phlebolog ltd. | Perm |
Lead Sponsor | Collaborator |
---|---|
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia |
Russian Federation,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Determination of the sensitivity and specificity | 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). | 1 day | |
Secondary | Number of participants with complications | Any serious adverse event will be recorded | 1 day |
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