Chronic Venous Disease, CVD
Conditions
Brief 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).
Interventions
OTHERto 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.
Sponsors
Servier Russia
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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 | 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
| Measure | Time frame | Description |
|---|---|---|
| Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. | 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. |
| Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Patients With CVD 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;
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. | 433 |
| Total | 433 |
Baseline characteristics
| Characteristic | Patients With CVD | — |
|---|---|---|
| Age, Continuous | 46 years STANDARD_DEVIATION 18.43 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Russia | 433 Participants | — |
| Sex: Female, Male Female | 332 Participants | — |
| Sex: Female, Male Male | 101 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 433 |
| other Total, other adverse events | 0 / 433 |
| serious Total, serious adverse events | 0 / 433 |
Outcome results
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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With CVD | 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. | 75.19 percentage of of positive cases |
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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With CVD | 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 | 86.51 percentage of negative cases |
Secondary
Calculation of the Negative Predictive Values (NPV) 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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With CVD | Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. | 89.15 percentage of negative predictive values |
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.
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With CVD | Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. | 70.29 percent of positive predictive values |