Vacuum-assisted Laser Ablation for large saphenous veins
Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)
This study is testing a new method called vacuum-assisted laser ablation to see if it works better and is safer than the traditional method for treating large varicose veins.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 184 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Center Of Phlebology Research network |
| Locations | 9 sites (Minsk and 8 other locations) |
| Trial ID | NCT06971068 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with varicose veins classified as C2-C6 and a diameter of the great or small saphenous veins of 15 mm or greater.
Not a fit: Patients with certain comorbidities, such as diabetes, severe liver or kidney diseases, or a history of acute deep vein thrombosis, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective treatment options for patients suffering from varicose veins.
How similar studies have performed: While there is existing research on endovenous thermal ablation, the specific use of vacuum-assisted techniques in this context is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Minsk and 8 other locations
- 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)
- Derzhavin Tambov State University — Tambov, Russia (Recruiting)
- Clinic of Modern Phlebology "VarikozOFF" — Tashkent, Uzbekistan (Recruiting)
- Clinic of Modern Phlebology "VarikozOFF" — Tashkent, Uzbekistan (Recruiting)
Study contacts
- Study coordinator: Dmitrii N Alekseev, PhD
- Email: dm.alekseev81@gmail.com
- Phone: +996555521274
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.