Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorAntonio Eduardo Zerati

About this trial

This study compares two minimally invasive treatments for varicose veins in the legs, specifically the great saphenous vein.

Varicose veins can cause symptoms such as leg pain, swelling, and skin changes. One commonly used treatment is foam sclerotherapy, where a special foam is injected into the vein to close it. This method is simple and allows patients to return quickly to their daily activities, but sometimes the vein can reopen, requiring additional treatments.

Another option is mechanochemical ablation, which combines a small device with a medication to close the vein. This method also allows for quick recovery and may have a lower chance of the vein reopening.

In this study, 50 patients with varicose veins will be randomly assigned to receive one of these two treatments. Doctors will follow patients over time to evaluate:

How well the treated vein stays closed Improvement in quality of life Pain during the procedure Possible complications All procedures are performed with local anesthesia, and additional small varicose veins are treated at the same time.

Eligibility criteria

Qualifiers

CEAP Classification C2, 3 or 4

Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.

Disqualifiers

Allergy to sclerosing substances

Deep venous thrombosis, stroke, or pulmonary embolism

Local or generalized infection at the sclerotherapy site

Prolonged immobilization

Trial design

Treatments tested in this trial

  • Flebogrif
  • Polidocanol foam sclerotherapy

Treatment groups

50 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Antonio Eduardo Zerati

Lead sponsor

University of Sao Paulo

Sponsor institution