Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS)

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Status: Enrolling

Conditions: Varicose Veins of Lower Limb; Telangiectasia

Treatments: Diagnostic Test: Determining of the clinical class of chronic venous disorders by artificial intelligence

Study type: Interventional

Funder types: Other

Identifiers

NCT05978986

17122021

Details and patient eligibility

About

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.

Enrollment: 1,530 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: Double Blind