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

CVD Clinical Trial

— AIVARIX  

Official 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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05612217
• Other study ID #: IC4-05682-071-RUS
• Status: Not yet recruiting
• Start date: December 1, 2022
• Est. completion date: September 1, 2023

Study information

• Verified date: November 2022
• Source: Servier Russia
• Contact: Olga Linnik
• Phone: +7 495 9370700
• Email: olga.linnik[@]servier.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 414
• Est. completion date: September 1, 2023
• Est. primary completion date: June 1, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Venous Disease
• CVD

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Pirogov Russian National Research Medical University	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Servier Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	1 month
Primary	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	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.	1 month
Secondary	Calculation of the positive predictive values (PPV) a of AIVARIX in detecting signs of C1 and C2 classes of chronic venous disease.	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.	1 month
Secondary	Calculation of the negative predictive values (PPV) a of AIVARIX in detecting signs of C1 and C2 classes of chronic venous disease.	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.	1 month