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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins of Lower Limb; Telangiectasia
• Intervention / Treatment: Diagnostic test: Determining of the clinical class of chronic venous disorders by artificial intelligence

• Study Type: Interventional
• Enrollment (Estimated): 1530
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Denis Borsuk; Phone Number: +79630777333; Email: borsuk-angio@mail.ru

Study Locations

• Russian Federation
  • Ekaterinburg, Russian Federation
    • Recruiting
    • Azbuka zdoroviya ltd.
    • Contact: Alexey Gasnikov
  • Ekaterinburg, Russian Federation
    • Recruiting
    • Vasculab ltd.
    • Contact: Denis Borsuk; Phone Number: 89630777333
  • Perm, Russian Federation
    • Recruiting
    • Phlebolog ltd.
    • Contact: Vladimir Denisov; Phone Number: 89028330007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determination of the sensitivity and specificity	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).	1 day

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Investigators: Study Chair: Denis Borsuk, VenoClinica, "Vasculab" ltd.

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2023
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): August 15, 2024

Study Registration Dates

• First Submitted: July 30, 2023
• First Submitted That Met QC Criteria: July 30, 2023
• First Posted (Actual): August 7, 2023

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Telangiectasis; Varicose Veins
• Other Study ID Numbers: 17122021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No