Vacuum-assisted Laser Ablation for large saphenous veins

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and effectiveness of vacuum-assisted laser ablation (VALA) compared to traditional endovenous laser ablation (EVLA) for treating large saphenous veins in patients with varicose veins. The study involves preoperative assessments using duplex ultrasound to measure vein diameters and determine the appropriate energy density for the procedure. Patients will undergo the procedure under local anesthesia, with the aim of reducing complications and improving recovery times associated with vein ablation. The trial focuses on patients with incompetent large saphenous veins measuring 15 mm or more.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age over 18 years
* Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position
* Informed consent

Exclusion Criteria:

* pregnancy or lactation
* malignant neoplasms
* inability or unwillingness of any patient to wear compression stockings
* hypersensitivity to lidocaine
* concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and/or soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia
* period after treatment for alcohol addiction
* sedentary lifestyle
* history of acute deep vein thrombosis
* history of superficial thrombophlebitis
* history of drug or other addiction
* use of oral contraceptives or other hormonal drugs

Where it's running

• Clinic in Uruchye
  Minsk, Belarus Recruiting
• Merci clinic
  Minsk, Belarus Recruiting
• SANTE clinic
  Minsk, Belarus Recruiting
• Center Of Phlebology
  Bishkek, Chuy Region, Kyrgyzstan Recruiting
• Laser Surgery Center
  Moscow, Russia Recruiting
• Innovative vascular centre
  Saint Petersburg, Russia Recruiting

Study contacts

• Study coordinator: Dmitrii N Alekseev, PhD
• Email: dm.alekseev81@gmail.com
• Phone: +996555521274

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.