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Completed

NCT Number: NCT05612217

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

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

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Key information

Conditions

Chronic Venous Disease CVD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Pirogov Russian National Research Medical University

Moscow, Russia

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age over 18 years
  • Written informed consent is provided
  • Symptoms and signs of CVD or any other skin pathologic condition (s) of lower extremities for which a patient seeks for phlebologist's consultation
  • Ability to fulfil the technical requirements for smartphones/ images

Exclusion criteria

  • Patients with mental/ psychiatric disabilities who are not able to understand objectives of the study and therefore provide a signed consent to participate in the study.
  • Patient's decision to withdraw his/her consent to participate in the study at any moment of the study conduction

Treatment and study plan

to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD

Other

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.

Primary outcomes

  1. Evaluation of Sensitivity (Sn) 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.

    Time frame: 1 month

    Sensitivity is defined as the ratio of the number of positive cases of detection of signs of C1 or C2 CVD, identified using the AIVARIX tool, to the total number of truly positive cases of C1 or C2 CVD in the study population, confirmed by phlebologists using objective / instrumental examinations.

  2. Evaluation of Specificity (Sp) 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

    Time frame: 1 month

    Specificity is defined as a proportion of the number of negative cases of signs C1 or C2 classes of CVD identified by the AIVARIX tool divided to overall truly negative cases of C1 or C2 in the study population confirmed by phlebologists by means of objective/ instrumental examination.

Secondary outcomes

  1. Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.

    Time frame: 1 month

    PPV is defined as the proportion of true positive cases of class C1 or C2 CVD detected using AIVARIX as a proportion of the number of true positive and false positive cases of class C 1 or C 2 identified using the AIVARIX application and confirmed by phlebologists.

  2. Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.

    Time frame: 1 month

    The NPV is defined as the ratio of the number of true negative cases of C 1 or C 2 CVD detected using AIVARIX to the true negative and false negative cases of C 1 or C 2 CVD detected using AIVARIX and confirmed by phlebologists.

Sponsors and collaborators

Lead sponsor

Servier Russia

Industry

Registry information

Official study title

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

Acronym: AIVARIX

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Nov 10, 2022
Registry last updated
Sep 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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