MedTrace Logo

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

NCT07561320 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Varicose Veins of Leg With Long Saphenous Vein Distribution
  • Varicose Veins of Lower Limb

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.

Sponsors & Collaborators

  • Antonio Eduardo Zerati

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-08-31
Completion
2027-11-30

Countries

  • Brazil

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07561320 on ClinicalTrials.gov