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

NCT05978986 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1622

Last updated 2026-03-06

No results posted yet for this study

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.

Conditions

  • Varicose Veins of Lower Limb
  • Telangiectasia

Interventions

DIAGNOSTIC_TEST

Determining of the clinical class of chronic venous disorders by artificial intelligence

The doctor takes pictures of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP. Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.

Sponsors & Collaborators

  • Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

    lead OTHER

Principal Investigators

  • Denis Borsuk · VenoClinica, "Vasculab" ltd.

Study Design

Allocation
NA
Purpose
SCREENING
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-25
Primary Completion
2026-02-23
Completion
2026-02-23

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978986 on ClinicalTrials.gov