Trial Outcomes & Findings for Evaluation of the AIVARIX in Detecting Signs C 1-2 Classes of CVD (NCT NCT05612217)

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

433 participants

Primary outcome timeframe

1 month

Results posted on

2024-09-25

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	433
Overall Study COMPLETED	433
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patients With CVD n=433 Participants 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.
Age, Continuous	46 years STANDARD_DEVIATION 18.43 • n=433 Participants
Sex: Female, Male Female	332 Participants n=433 Participants
Sex: Female, Male Male	101 Participants n=433 Participants
Region of Enrollment Russia	433 Participants n=433 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD n=433 Participants 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.
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 Interval 66.82 to 82.37

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD n=433 Participants 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.
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 Interval 82.15 to 90.14

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD n=433 Participants 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.
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 Interval 61.92 to 77.76

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Patients With CVD n=433 Participants 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.
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 Interval 85.03 to 92.46

Adverse Events

Patients With CVD

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

olga linnik

Servier

Phone: 8-495-93707-00

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place