N/A
N=433
Evaluation of the AIVARIX in Detecting Signs C 1-2 Classes of CVD
Chronic Venous Disease · CVD
Bottom Line
View on ClinicalTrials.gov: NCT05612217 ↗Enrolled (actual)
433
Serious AEs
0.0%
Results posted
Sep 2024
Primary outcome: 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. — 75.19 percentage of of positive cases
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Servier Russia
- Primary completion
- Jun 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
75.19 | — |
| 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 |
86.51 | — |
| SECONDARY Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. |
70.29 | — |
| SECONDARY Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease. |
89.15 | — |
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
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
Data sourced from ClinicalTrials.gov (NCT05612217). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.