Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein
Recruiting now · Phase 4
Conditions studied: Varicose Veins of Leg With Long Saphenous Vein Distribution, Varicose Veins of Lower Limb
In brief
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.
Key facts
- Study ID
- NCT07561320
- Run by
- Antonio Eduardo Zerati
- People needed
- 50
- Starts
- 2026-05-01
- Expected to finish
- 2027-11-01
- Last updated by the study team
- 2026-05-01
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- CEAP Classification C2, 3 or 4
- Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.
You may not qualify if…
- 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
Where it is running
- Hospital da Clínicas da FMUSP — São Paulo, São Paulo, Brazil (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.