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

NCT05612217 | Completed Results

• 1 other identifier: IC4-05682-071-RUS
• Study Type: observational
• Target: 433
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Venous Disease; CVD

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

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

  1 month

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

  1 month

Study Arms (1)

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;

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

Interventions

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.

patients with CVD

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients who are consulted by phlebologists on symptoms and signs suggestive to CVD.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Servier Russia: lead

Study Sites (1)

Pirogov Russian National Research Medical University

Moscow, Russia

Location

Results Point of Contact

• Title: olga linnik
• Organization: Servier

olga.linnik@servier.com

8-495-93707-00

Study Officials

• IGOR ZOLOTUKHIN

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2022
• First Posted: November 10, 2022
• Study Start: December 1, 2022
• Primary Completion: June 1, 2023
• Study Completion: April 1, 2024
• Last Updated: September 25, 2024
• Results First Posted: September 25, 2024

Record last verified: 2024-09

Locations

RU (1)