Back to resultsEfficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS)
Primary Purpose
Varicose Veins of Lower Limb, Telangiectasia
Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Determining of the clinical class of chronic venous disorders by artificial intelligence
Sponsored by
About this trial
This is an interventional screening trial for Varicose Veins of Lower Limb
Eligibility 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.
Sites / Locations
- Azbuka zdoroviya ltd.Recruiting
- Vasculab ltd.Recruiting
- Phlebolog ltd.Recruiting
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Number of participants with complications
Any serious adverse event will be recorded
Full Information
NCT ID
NCT05978986
First Posted
July 30, 2023
Last Updated
August 26, 2023
Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
1. Study Identification
Unique Protocol Identification Number
NCT05978986
Brief Title
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence
Acronym
IVENUS
Official Title
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
January 15, 2024 (Anticipated)
Study Completion Date
May 15, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins of Lower Limb, Telangiectasia
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
Care ProviderInvestigator
Allocation
N/A
Enrollment
1530 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Diagnostic Test
Intervention Name(s)
Determining of the clinical class of chronic venous disorders by artificial intelligence
Intervention Description
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.
Primary Outcome Measure Information:
Title
Determination of the sensitivity and specificity
Description
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).
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of participants with complications
Description
Any serious adverse event will be recorded
Time Frame
1 day
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Denis Borsuk
Phone
+79630777333
Email
borsuk-angio@mail.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Denis Borsuk
Organizational Affiliation
VenoClinica, "Vasculab" ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Azbuka zdoroviya ltd.
City
Ekaterinburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexey Gasnikov
Facility Name
Vasculab ltd.
City
Ekaterinburg
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Denis Borsuk
Phone
89630777333
Facility Name
Phlebolog ltd.
City
Perm
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir Denisov
Phone
89028330007
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence
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