Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence

NCT ID: NCT05978986

Last Updated: 2025-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1530 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-08-25

Study Completion Date

2025-12-15

Brief Summary

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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.

Detailed Description

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Conditions

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Varicose Veins of Lower Limb Telangiectasia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Caregivers Investigators

Interventions

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Determining of the clinical class of chronic venous disorders by artificial intelligence

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

OTHER

Sponsor Role lead

Responsible Party

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Denis Borsuk

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Denis Borsuk

Role: STUDY_CHAIR

VenoClinica, "Vasculab" ltd.

Locations

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Phlebolog ltd.

Perm, , Russia

Site Status RECRUITING

Azbuka zdoroviya ltd.

Yekaterinburg, , Russia

Site Status RECRUITING

Vasculab ltd.

Yekaterinburg, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Denis Borsuk

Role: CONTACT

+79630777333

Facility Contacts

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Vladimir Denisov

Role: primary

89028330007

Alexey Gasnikov

Role: primary

Denis Borsuk

Role: primary

89630777333

Other Identifiers

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17122021

Identifier Type: -

Identifier Source: org_study_id

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