Varicose Veins of Lower LimbRRT CVDNCT03035747
Ongoing Registry of Treatment of Chronic Venous Diseases
An observational study of Varicose Veins of Lower Limb, run by Medalp Private Surgery Clinic at 1 site in Russia.
Trial summary
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins of Lower Limb
- What is being tested?
- conventional surgery, endovenous laser ablation and sclerotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 5,000 participants
- Where
- 1 siteRussia
- Study dates
- Jul 2016to Jul 2036
- How long will I take part?
- 12 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing interventions in cases varicose vein disease
Who may be able to join
- Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification
Who cannot join
- no exclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
Medalp private surgery clinic
Saint Petersburg, 197758
Oleg Shonov, MD, shonov.o@gmail.com
About this study
Official title: Russian Registry of Treatment of Chronic Venous Diseases
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
Read the detailed description
Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.
There is planned to conduct prospective randomized, cohort and observational studies on the site of register
- Conditions
- Varicose Veins of Lower Limb
- Being tested
- conventional surgery, endovenous laser ablation, sclerotherapy, endovenous radiofrequency ablation, phlebectomy
- Keywords
- registry, varicose veins, conventional surgery, thermal ablation, radiofrequency, laser, sclerotherapy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional surgeryProcedure or surgery
high ligation and stripping of incompetent saphenous veins
endovenous laser ablationProcedure or surgery
endovenous laser ablation of incompetent saphenous veins
sclerotherapyProcedure or surgery
ultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins
endovenous radiofrequency ablationProcedure or surgery
endovenous radiofrequency ablation of incompetent saphenous veins
phlebectomyProcedure or surgery
hooks phlebectomy of varicose veins
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods
Measured: Baseline, 3 - 6, 12 months post-intervention
Secondary outcomes (3)
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)
The SF-36 is a generic QoL questionnaire.
Measured: Baseline, 3 and 12 months post-intervention
Change in Venous Clinical Severity Score (VCSS) (optional)
The VCSS is a validated scoring system for assessing signs, symptoms and complaints of venous disease.
Measured: Baseline, 3 and 12 months post-intervention
Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)
The AVVQ is a disease-specific QoL questionnaire aimed at venous disease.
Measured: Baseline, 3 and 12 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startJul 2016
- Primary completionJul 2036 (estimated)
- Study completionJul 2036 (estimated)
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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Medalp Private Surgery Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Responsible party
- Principal investigator, Evgeny Ilyukhin, Medalp Private Surgery Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035747
- Sponsor's protocol ID
- A001
- Acronym
- RRT CVD
- Status last verified
- Mar 2024
- First submitted
- 25 Jan 2017
- Last updated
- 13 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Russian Registry of Treatment of Chronic Venous Diseases
- ClinicalTrials.gov ID
- NCT03035747
- Acronym / sponsor ID
- RRT CVD / A001
- Conditions
- Varicose Veins of Lower Limb
- Keywords
- registry, varicose veins, conventional surgery, thermal ablation, radiofrequency, laser, sclerotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medalp Private Surgery ClinicUniversity, hospital or other
- Collaborators
- Pirogov Russian National Research Medical University
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2036 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 30 Jan 2017 (estimated)
- 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.
Ongoing registration of patients with varicose veins disease treated by means of conventional surgery, endovenous thermal ablations, sclerotherapy, non-tumescent non-thermal methods
Detailed description
Data of patients treated in different Russian medical centers are entered in a prospective digital database, and continuously updated.
There is planned to conduct prospective randomized, cohort and observational studies on the site of register
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 12 Months
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing interventions in cases varicose vein disease
Key inclusion criteria (1 listed)
- Varicose veins with any source of pathological reflux, C2 - C6 according to the CEAP classification
Key exclusion criteria (1 listed)
- no exclusion criteria
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 |
|---|---|---|
| conventional surgeryhigh ligation and stripping of incompetent saphenous veins | Procedure or surgery | – |
| endovenous laser ablationendovenous laser ablation of incompetent saphenous veins | Procedure or surgery | – |
| sclerotherapyultrasound guided or catheter or or any other methods sclerotherapy of incompetent saphenous or varicose veins | Procedure or surgery | – |
| endovenous radiofrequency ablationendovenous radiofrequency ablation of incompetent saphenous veins | Procedure or surgery | – |
| phlebectomyhooks phlebectomy of varicose veins | Procedure or surgery | – |
Primary outcome
Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods
Time frame: Baseline, 3 - 6, 12 months post-intervention
3 secondary outcomes
Change in Quality of Life (QoL), assessed by Short form (SF)-36 health survey (optional)
Time frame: Baseline, 3 and 12 months post-intervention
Change in Venous Clinical Severity Score (VCSS) (optional)
Time frame: Baseline, 3 and 12 months post-intervention
Change in Quality of Life (QoL), assessed by Aberdeen Varicose Vein Questionnaire (AVVQ) (optional)
Time frame: Baseline, 3 and 12 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2024.
- Russian Register of Treatment of Chronic Venous Diseases (RRT CVD)Link provided by the sponsor.
- Russian Phlebological Association (RPA)Link provided by the sponsor.
- Confirmation page about membership of RPA in the International Union of PhlebologyLink provided by the sponsor.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins of Lower Limb, run by Medalp Private Surgery Clinic at 1 site 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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 13 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Evgeny Ilyukhin, MD, PhD (+79218451722, evgeny@ilyukhin.info), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patency target veins assessed by duplex ultrasonography in different follow up periods after conventional surgery, endovenous thermal ablations, sclerotherapy or non-tumescent non-thermal methods (time frame: Baseline, 3 - 6, 12 months post-intervention). 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 13 Mar 2024.