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RECRUITING
NCT07561320
PHASE4

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

Sponsor: Antonio Eduardo Zerati

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-05

Completion Date

2027-11

Last Updated

2026-05-01

Healthy Volunteers

No

Interventions

DEVICE

Flebogrif

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

DRUG

Polidocanol 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