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

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

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05978986

Acronym

IVENUS

Enrollment

1622

Registered

2023-08-07

Start date

2023-08-25

Completion date

2026-02-23

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Telangiectasia, Varicose Veins of Lower Limb

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.

Interventions

DIAGNOSTIC_TESTDetermining 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Number of participants with complications	1 day	Any serious adverse event will be recorded

Countries

Russia

Contacts

STUDY_CHAIRDenis Borsuk

VenoClinica, "Vasculab" ltd.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026