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

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.

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Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Telangiectasia Telangiectasis Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phlebolog ltd., Perm, Russia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Diagnostic Test

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.

Primary outcomes

Determination of the sensitivity and specificity

Time frame: 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 outcomes

Number of participants with complications

Time frame: 1 day

Any serious adverse event will be recorded

Sponsors and collaborators

Lead sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Other

Registry information

Official study title

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

Acronym: IVENUS

Important dates

Study start: 2023
Primary completion: 2026
Study completion: 2026
First posted: Aug 7, 2023
Registry last updated: Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed