Actively Recruiting

Phase 4
Age: 18Years +
All Genders
NCT07561320

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

Led by Antonio Eduardo Zerati · Updated on 2026-05-01

50

Participants Needed

1

Research Sites

78 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • CEAP Classification C2, 3 or 4
  • Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital da Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Actively Recruiting

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Research Team

A

Antonio Zerati, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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