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

Servier

Status: Completed

Conditions: CVD; Chronic Venous Disease

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

Study type: Observational

Funder types: Industry

Identifiers

NCT05612217

IC4-05682-071-RUS

Details and patient eligibility

About

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

Full 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).

Enrollment: 433 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

433 participants in 1 patient group

patients with CVD

Description:

20 patients per 1 center: patients with CVD C1 class 4 patients with CVD C2 class; 2 patients with CVD with classes other than C1-C2 (C4-C6); 8 patients with either C0s CVD or with skin pathologic conditions of lower extremities other than CVD;

Treatment:

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