RecruitingPhase 4NCT07561320

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

Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial


Sponsor

Antonio Eduardo Zerati

Enrollment

50 participants

Start Date

May 1, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 18 Years

Inclusion Criteria2

  • CEAP Classification C2, 3 or 4
  • Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.

Exclusion Criteria6

  • Allergy to sclerosing substances
  • Deep venous thrombosis, stroke, or pulmonary embolism
  • Local or generalized infection at the sclerotherapy site
  • Prolonged immobilization
  • Asymptomatic patent foramen ovale
  • Pregnancy Occlusive peripheral arterial disease

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Interventions

DEVICEFlebogrif

Mechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam.

DRUGPolidocanol foam sclerotherapy

Polidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium.


Locations(1)

Hospital da Clínicas da FMUSP

São Paulo, São Paulo, Brazil

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NCT07561320


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