Using artificial intelligence to classify chronic venous disorders
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
NA · Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia · NCT05978986
This study is testing an app that uses artificial intelligence to see if it can accurately classify chronic venous disorders like varicose veins based on photos taken by doctors, to compare its results with the doctors' own assessments.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 1530 (estimated) |
| Sex | All |
| Sponsor | Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia (other) |
| Locations | 3 sites (Ekaterinburg and 2 other locations) |
| Trial ID | NCT05978986 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the Ivenus application in determining the clinical class of chronic venous diseases, specifically focusing on varicose veins and telangiectasia. Patients visiting phlebology clinics for initial consultations will have their lower extremity photographs taken by experienced doctors, who will then upload these images to the Ivenus application. The application will automatically classify the condition according to the CEAP system without revealing results to the surgeon, allowing for a comparison with the doctor's independent assessment. This multicenter prospective study aims to assess the sensitivity and specificity of this AI-based method.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals classified as C0-C2 according to the CEAP classification of chronic venous disorders.
Not a fit: Patients with more advanced chronic venous disorders classified as C3-C6 or those with skin diseases of the lower extremities will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could enhance the accuracy and efficiency of diagnosing chronic venous disorders, leading to better patient management.
How similar studies have performed: While the use of artificial intelligence in medical diagnostics is gaining traction, this specific application for classifying chronic venous disorders is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * C0-C2 CEAP clinical class; * Signed consent to take part in investigation. Exclusion Criteria: * C3-C6 CEAP clinical class; * Skin diseases of the lower extremities; * Immobilization.
Where this trial is running
Ekaterinburg and 2 other locations
- Azbuka zdoroviya ltd. — Ekaterinburg, Russian Federation (RECRUITING)
- Vasculab ltd. — Ekaterinburg, Russian Federation (RECRUITING)
- Phlebolog ltd. — Perm, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: Denis Borsuk
- Email: borsuk-angio@mail.ru
- Phone: +79630777333
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Varicose Veins of Lower Limb, Telangiectasia