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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05978986
Other study ID # 17122021
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 25, 2023
Est. completion date August 15, 2024

Study information

Verified date February 2024
Source Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Contact Denis Borsuk
Phone +79630777333
Email borsuk-angio@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 1530
Est. completion date August 15, 2024
Est. primary completion date June 15, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
Russian Federation Azbuka zdoroviya ltd. Ekaterinburg
Russian Federation Vasculab ltd. Ekaterinburg
Russian Federation Phlebolog ltd. Perm

Sponsors (1)

Lead Sponsor Collaborator
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Number of participants with complications Any serious adverse event will be recorded 1 day
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