Varicose Veins of Lower LimbIVENUSNCT05978986
Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence
A study testing Determining of the clinical class of chronic venous disorders by artificial intelligence in people with Varicose Veins of Lower Limb and Telangiectasia, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 3 sites in Russia.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Varicose Veins of Lower Limb, Telangiectasia
- What is being tested?
- Determining of the clinical class of chronic venous disorders by artificial intelligence
- How many people
- 1,622 participants
- Where
- 3 sitesRussia
- Study dates
- 25 Aug 2023to 23 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- C0-C2 CEAP clinical class;
- Signed consent to take part in investigation.
Who cannot join
- C3-C6 CEAP clinical class;
- Skin diseases of the lower extremities;
- Immobilization.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
Phlebolog ltd.
Perm
Azbuka zdoroviya ltd.
Yekaterinburg
Vasculab ltd.
Yekaterinburg
About this study
Official title: Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
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.
- Conditions
- Varicose Veins of Lower Limb, Telangiectasia
- Being tested
- Determining of the clinical class of chronic venous disorders by artificial intelligence
- Medical subject headings
- Telangiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Determining of the clinical class of chronic venous disorders by artificial intelligenceDiagnostic test
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 1 day
Secondary outcomes (1)
Number of participants with complications
Any serious adverse event will be recorded
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start25 Aug 2023
- Primary completion23 Feb 2026
- Study completion23 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Varicose Veins of Lower LimbStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Care provider, Investigator
- Enrolment
- 1,622 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Denis Borsuk, Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Investigators
- Denis Borsuk, Study chair, VenoClinica, "Vasculab" ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978986
- Sponsor's protocol ID
- 17122021
- Acronym
- IVENUS
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficiency of Determining the Clinical Class of Chronic Venous Disorders by Artificial Intelligence (IVENUS App)
- ClinicalTrials.gov ID
- NCT05978986
- Acronym / sponsor ID
- IVENUS / 17122021
- Conditions
- Varicose Veins of Lower Limb, Telangiectasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,622 participants (actual)
- Lead sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, RussiaUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 23 Feb 2026 (actual)
- Study completion
- 23 Feb 2026 (actual)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- Double blind (care provider, investigator)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- C0-C2 CEAP clinical class;
- Signed consent to take part in investigation.
Key exclusion criteria (3 listed)
- C3-C6 CEAP clinical class;
- Skin diseases of the lower extremities;
- Immobilization.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Determining of the clinical class of chronic venous disorders by artificial intelligenceThe 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. | Diagnostic test | – |
Primary outcome
Determination of the sensitivity and specificity
Time frame: 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).
1 secondary outcome
Number of participants with complications
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Denis Borsuk study chair
VenoClinica, "Vasculab" ltd.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Determining of the clinical class of chronic venous disorders by artificial intelligence in people with Varicose Veins of Lower Limb and Telangiectasia, run by Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of the sensitivity and specificity (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.