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CompletedNCT05978986IVENUSUpdated Mar 6, 2026

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

An interventional study of Determining of the clinical class of chronic venous disorders by artificial intelligence in Varicose Veins of Lower Limb and Telangiectasia, sponsored by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia. Completed at 3 sites in Russia. Per ClinicalTrials.gov, last updated 2026-03-06.

Sponsored by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia · Not applicable, Interventional, and Screening

Phase
Not applicable
Study type
Interventional
Enrollment
1,622
Allocation
Not applicable
Sex
All
01

Study 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.

02

Conditions studied

  • Varicose Veins of Lower Limb
  • Telangiectasia

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03

In context

Telangiectasis

69 studies on the registry are indexed under Telangiectasis; 12 are open to participants now.

This study's enrollment of 1,622 is above the median of 30 across 59 interventional studies indexed under Telangiectasis.

Browse Telangiectasis studies →

Lead sponsor

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • C0-C2 CEAP clinical class;
  • Signed consent to take part in investigation.

Exclusion criteria

Exclusion Criteria:

  • C3-C6 CEAP clinical class;
  • Skin diseases of the lower extremities;
  • Immobilization.
05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
Double (Care provider, Investigator)
Enrollment
1,622 participants (actual)

Interventions

  • Diagnostic testDetermining 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.

06

What researchers measure

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).

    Time frame: 1 day

Secondary outcomes

  1. Number of participants with complications

    Any serious adverse event will be recorded

    Time frame: 1 day

07

Study locations

3 sites
  • Phlebolog ltd.
    Perm, Russia
  • Azbuka zdoroviya ltd.
    Yekaterinburg, Russia
  • Vasculab ltd.
    Yekaterinburg, Russia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Aug 2023 to primary completion in Feb 2026, 29 months.

Of 14 interventional studies with no phase under Telangiectasis, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 8 and three quarters within 27. This study's 29 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 30, 2023
First posted
Aug 7, 2023
StartActual
Aug 25, 2023
Primary completionActual
Feb 23, 2026
CompletionActual
Feb 23, 2026
Last update
Mar 6, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05978986
Lead sponsor
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Responsible party
Denis Borsuk (Director, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia) — Principal investigator
First posted
Aug 7, 2023
Start date
Aug 25, 2023
Primary completion
Feb 23, 2026
Completion
Feb 23, 2026
Last update
Mar 6, 2026

Study contacts

Denis Borsuk
study chair · VenoClinica, "Vasculab" ltd.

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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