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

Varicose Veins of Lower Limb Clinical Trial

— IVENUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05978986
• Other study ID #: 17122021
• Status: Recruiting
• Phase: N/A
• Start date: August 25, 2023
• Est. completion date: August 15, 2024

Study information

• Verified date: February 2024
• Source: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Contact: Denis Borsuk
• Phone: +79630777333
• Email: borsuk-angio[@]mail.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1530
• Est. completion date: August 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Telangiectasia
• Telangiectasis
• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Azbuka zdoroviya ltd.	Ekaterinburg
Russian Federation	Vasculab ltd.	Ekaterinburg
Russian Federation	Phlebolog ltd.	Perm

Sponsors (1)

Lead Sponsor	Collaborator
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

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