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

Not Applicable

Recruiting

• Conditions: Varicose Veins of Lower Limb; Telangiectasia

• Registration Number: NCT05978986
• Lead Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-30
• Study First Submitted QC: 2023-07-30
• Study First Posted: 2023-08-07
• Study Start: 2023-08-25
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2024-11-15
• Study Completion: 2024-12-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1530

Inclusion Criteria

• C0-C2 CEAP clinical class;
• Signed consent to take part in investigation.

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Exclusion Criteria

• C3-C6 CEAP clinical class;
• Skin diseases of the lower extremities;
• Immobilization.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Determination of the sensitivity and specificity	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).

Secondary Outcome Measures

Name	Time	Method
Number of participants with complications	1 day	Any serious adverse event will be recorded

Trial Locations

Locations (3)

Vasculab ltd.; 🇷🇺 Ekaterinburg, Russian Federation

Phlebolog ltd.; 🇷🇺 Perm, Russian Federation

Azbuka zdoroviya ltd.; 🇷🇺 Ekaterinburg, Russian Federation