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

Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05978986
Collaborator
(none)
1,530
Enrollment
9
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Determining of the clinical class of chronic venous disorders by artificial intelligence
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1530 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
Double (Care Provider, Investigator)
Primary Purpose:
Screening
Official Title:
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
Anticipated Study Start Date :
Aug 15, 2023
Anticipated Primary Completion Date :
Jan 15, 2024
Anticipated Study Completion Date :
May 15, 2024

Outcome Measures

Primary Outcome Measures

  1. Determination of the sensitivity and specificity [1 day]

    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).

Secondary Outcome Measures

  1. Number of participants with complications [1 day]

    Any serious adverse event will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Investigators

  • Study Chair: Denis Borsuk, VenoClinica, "Vasculab" ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Denis Borsuk, Director, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
ClinicalTrials.gov Identifier:
NCT05978986
Other Study ID Numbers:
  • 17122021
First Posted:
Aug 7, 2023
Last Update Posted:
Aug 10, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Telangiectasis
Varicose Veins

Study Results

No Results Posted as of Aug 10, 2023