Status:

RECRUITING

Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins

Lead Sponsor:

Center Of Phlebology

Conditions:

Varicose Veins

Eligibility:

All Genders

18-90 years

Phase:

NA

Brief Summary

Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. Ho...

Detailed Description

Preoperatively all patients should be examined in a standing position clinically and with duplex ultrasound (DUS) marking of the diameters of the target great saphenous veins (GSV) or small saphenous ...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

March 15 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 15 2026

Estimated Enrollment :

184 Patients enrolled

Trial Details

Trial ID

NCT06971068

Start Date

March 15 2025

End Date

February 15 2026

Last Update

May 14 2025

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Clinic in Uruchye

Minsk, Belarus

2

Merci clinic

Minsk, Belarus

3

SANTE clinic

Minsk, Belarus

4

Center Of Phlebology

Bishkek, Chuy Region, Kyrgyzstan, 720023