Chronic Venous DiseaseAIVARIXNCT05612217

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

An observational study of Chronic Venous Disease and CVD, run by Servier Russia at 1 site in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Venous Disease, CVD
What is being tested?: to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD
How many people: 433 participants
Where: 1 siteRussia
Study dates: 1 Dec 2022to 1 Apr 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Russia1 site

Pirogov Russian National Research Medical University
Moscow

Other trials in Russia

About this study

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

Read the 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).

Conditions: Chronic Venous Disease, CVD
Being tested: to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVDOther
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.

Study groups in NCT05612217
Study group	Role	What they receive
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; Receives: Other: to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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.
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.
Measured: 1 month
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.
Measured: 1 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20221 Apr 2024

First posted10 Nov 2022
Study start1 Dec 2022
Primary completion1 Jun 2023
Study completion1 Apr 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Venous DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Cross-sectional
Enrolment: 433 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05612217
Sponsor's protocol ID: IC4-05682-071-RUS
Acronym: AIVARIX
Status last verified: Sep 2024
First submitted: 3 Nov 2022
Last updated: 25 Sep 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Chronic Venous Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05612217
Acronym / sponsor ID: AIVARIX / IC4-05682-071-RUS
Conditions: Chronic Venous Disease, CVD
Study type: Observational
Recruitment status: Completed
Enrolment: 433 participants (actual)
Lead sponsor: Servier RussiaIndustry (pharma, biotech, devices)
Study start: 1 Dec 2022 (actual)
Primary completion: 1 Jun 2023 (actual)
Study completion: 1 Apr 2024 (actual)
First posted: 10 Nov 2022 (actual)
Results: Posted 25 Sep 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

At single visit, investigating physicians (phlebologists) will be assessing and collecting parameters of interest which they should input in eCRF.

Study design

Observational model: Other
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
patients with CVD	–	Other: to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVD20 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;

Who may qualify

Ages: 18 years and older
Sex: All
Age groups: Adult, Older adult
Study population: patients who are consulted by phlebologists on symptoms and signs suggestive to CVD.

Key inclusion criteria (4 listed)

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

Key exclusion criteria (2 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
to estimate Sensitivity and Specificity AIVARIX app in detecting C1 and C2 classes of CVDto 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.	Other	patients with CVD

Primary outcome

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.
Time frame: 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
Time frame: 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.

2 secondary outcomes

Calculation of the Positive Predictive Values (PPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.
Time frame: 1 month
Calculation of the Negative Predictive Values (NPV) a of AIVARIX in Detecting Signs of C1 and C2 Classes of Chronic Venous Disease.
Time frame: 1 month

Results and safety

Results posted to the registry on 25 Sep 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients With CVD	433	433

Primary outcome: 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.

Time frame: 1 month. Number (95% Confidence Interval). Unit: percentage of of positive cases

Measure	Patients With CVD n = 433
Value	75.19 (66.82 to 82.37)

Primary outcome: 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

Time frame: 1 month. Number (95% Confidence Interval). Unit: percentage of negative cases

Measure	Patients With CVD n = 433
Value	86.51 (82.15 to 90.14)

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 month. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Patients With CVD	0 of 433 (0%)	0 of 433 (0%)	0 of 433

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Chronic Venous Disease

Recruiting
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Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
RecruitingPhase 4
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Telangiectasias, Reticular Veins
Recruiting
Efficacy and Safety of ZKARE® Gel and Its Accessory ZKAPI® in the Treatment of Chronic Ulcers.
Chronic Ulcers
Not yet recruiting
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Varicose Veins
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A Study to Evaluate AZD7760 Safety and Pharmacokinetics in Healthy Adults (Phase I) and Adults With End-stage Kidney Disease on Hemodialysis With a Central Venous Catheter (Phase IIa)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

IGOR ZOLOTUKHIN principal investigator

Pirogov Russian National Research Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Venous Disease and CVD, run by Servier Russia at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05612217.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2024.