Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence
IVENUS
1 other identifier
interventional
1,622
1 country
3
Brief Summary
Purpose: To evaluate the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases using the Ivenus application (within C0-C2 according to CEAP). Materials and methods: Patients who applied to several phlebology clinics for an initial consultation are consistently included in a multicenter prospective study. At the appointment, a doctor with at least 5 years of experience takes photographs of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP, without showing the results to the surgeon (blinding). Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register. The object of the study is a photograph of a certain area of the lower limb.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2023
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 30, 2023
CompletedFirst Posted
Study publicly available on registry
August 7, 2023
CompletedStudy Start
First participant enrolled
August 25, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 23, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
February 23, 2026
CompletedMarch 6, 2026
March 1, 2026
2.5 years
July 30, 2023
March 4, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Determination of the sensitivity and specificity
Determination of the sensitivity and specificity of the method for determining the clinical class of chronic venous diseases according to the CEAP classification using the IVENUS application (within C0-C2 classes).
1 day
Secondary Outcomes (1)
Number of participants with complications
1 day
Interventions
The doctor takes pictures of the lower extremities and uploads them to the IVENUS application, which automatically determines the clinical class according to CEAP. Further, the doctor independently determines the clinical class according to CEAP and enters the data into the register.
Eligibility Criteria
You may qualify if:
- C0-C2 CEAP clinical class;
- Signed consent to take part in investigation.
You may not qualify if:
- C3-C6 CEAP clinical class;
- Skin diseases of the lower extremities;
- Immobilization.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Phlebolog ltd.
Perm, Russia
Azbuka zdoroviya ltd.
Yekaterinburg, Russia
Vasculab ltd.
Yekaterinburg, Russia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Denis Borsuk
VenoClinica, "Vasculab" ltd.
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- DOUBLE
- Who Masked
- CARE PROVIDER, INVESTIGATOR
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
July 30, 2023
First Posted
August 7, 2023
Study Start
August 25, 2023
Primary Completion
February 23, 2026
Study Completion
February 23, 2026
Last Updated
March 6, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share