NCT05612217

Evaluation of the AIVARIX in Detecting Signs C 1-2 Classes of CVD

A Study to Evaluate a Accuracy of the AIVARIX AI-based Application in Detecting Signs C 1-2 Classes of CVD in Outpatients Seeking Consultancy of Phlebologists in the Russian Federation

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 433 (actual)
• Sponsor: Servier Russia · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

This study is a multicenter observational study, which is carried out in frame of routine clinical practice in Russia. The program will include patients suggestive to chronic venous diseases (CVDs) including but not limited to those with C1 and C2 classes by CEAP classification, who will be seeking professional phlebologists' consultation. Study conduction is scheduled in Russia in 2022-2023. The planned number of patients is 414

Detailed description

The main goal of this study is to describe the AIVARIX app accuracy in detecting C1 and C2 classes by CEAP classification of chronic venous disease (CVD) in patients who are consulted by phlebologists on symptoms and signs suggestive to CVD. At single visit, investigating physicians (phlebologists) will be assessing and collecting parameters of interest which they should input in eCRF. Following data will be collected at the visit: a signed consent form from a patient, demographic characteristics (age, sex), eligibility of a patient to the inclusion/ non-inclusion criteria, 1 (one) image of skin area of interest, conclusion on presence or absence of CVD or any other pathologic condition(s) made as a result of objective/ instrumental examination. In case there will be any information related to safety of a Servier drug provided, investigating physician will also collect the information and fill in the PV form (Appendix 1).

Conditions

• Chronic Venous Disease
• CVD

Interventions

Type	Name	Description
OTHER	to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD	to estimate Sensitivity and Specificity of the AI-based AIVARIX app in detecting C1 and C2 classes of CVD in patients who are seeking for professional advice from a phlebologist regarding symptoms and signs suggestive to CVD.

Timeline

• Start date: 2022-12-01
• Primary completion: 2023-06-01
• Completion: 2024-04-01
• First posted: 2022-11-10
• Last updated: 2024-09-25
• Results posted: 2024-09-25

Locations

1 site across 1 country: Russia