Clinical trial NCT05612217: Evaluation of the AIVARIX in Detecting Signs C 1-2 Classes of CVD
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Venous Disease
CVD
Lead sponsor: Servier Russia
Sponsor class: INDUSTRY
First posted: 2022-11-10
Enrollment: 433
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients who are consulted by phlebologists on symptoms and signs suggestive to CVD.

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).

Eligibility criteria: 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

Primary outcomes:
measure: 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.
timeFrame: 1 month
measure: 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
timeFrame: 1 month
Secondary outcomes:
measure: Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.
timeFrame: 1 month
measure: Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.
timeFrame: 1 month
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Pirogov Russian National Research Medical University
Study officials:
affiliation: Pirogov Russian National Research Medical University
name: IGOR ZOLOTUKHIN
role: PRINCIPAL_INVESTIGATOR
References: