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

NCT05978986 — Not applicable, Completed, 1622 participants, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

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

Registry	NCT05978986, acronym IVENUS
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: double, screening
Enrollment	1622 (Actual)
Sponsor	Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia (Other)
Conditions	Varicose Veins of Lower Limb, Telangiectasia
Interventions	Determining of the clinical class of chronic venous disorders by artificial intelligence (Diagnostic test)
Dates	start 2023-08-25, primary completion 2026-02-23, completion 2026-02-23, first posted 2023-08-07, last updated 2026-03-06
Locations	3 sites in Russia

-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.

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+Arms and interventions

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.

+Outcome measures

Primary outcomes

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 outcomes

Number of participants with complications [1 day]: Any serious adverse event will be recorded

+Eligibility

Sex: All

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.

+Locations (3)

Facility	City	Country
Phlebolog ltd.	Perm	Russia
Azbuka zdoroviya ltd.	Yekaterinburg	Russia
Vasculab ltd.	Yekaterinburg	Russia

+Investigators

Denis Borsuk, Study chair, VenoClinica, "Vasculab" ltd.