Mechanochemical ablation versus ultrasound-guided polidocanol foam sclerotherapy for great saphenous vein varicose veins
Official title: Mechanochemical Ablation Versus Ultrasound-Guided Foam Sclerotherapy of the Great Saphenous Vein: Randomized Clinical Trial
Run by University of Sao Paulo · NCT07561320 · Data updated 2026-11-12
This compares mechanochemical ablation and ultrasound-guided polidocanol foam sclerotherapy to see which better closes the great saphenous vein and improves symptoms in adults with symptomatic varicose veins.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Sao Paulo Academic / other |
| Locations | 1 site (São Paulo, São Paulo) |
| Status | Recruiting |
| Started | May 2026 |
| Main results expected | August 2027 |
| Study ends | November 2027 |
| Registry record updated | May 1, 2026 |
| Trial ID | NCT07561320 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with symptomatic varicose veins classified CEAP C2–C4 and ultrasound-confirmed great saphenous vein insufficiency measuring 6–12 mm at mid-thigh, who are eligible for minimally invasive endovenous treatment, are ideal candidates.
✕Probably not a fit
People with active deep vein thrombosis, recent pulmonary embolism or stroke, allergy to sclerosing agents, pregnancy, occlusive peripheral arterial disease, or GSV outside the 6–12 mm range are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Fifty patients with symptomatic varicose veins (CEAP C2–C4) and an insufficient great saphenous vein 6–12 mm in diameter will be randomized to either mechanochemical ablation using the Flebogrif® catheter or ultrasound-guided polidocanol foam sclerotherapy. Procedures are performed under ultrasound guidance and patients are followed with clinical exams and Doppler ultrasonography to document vein occlusion over the follow-up period. Primary endpoints are GSV occlusion rate on duplex ultrasound and disease-specific quality of life; secondary endpoints include procedure pain and treatment-related complications. This single-center, randomized Phase 4 comparison is conducted at Hospital das Clínicas da FMUSP in São Paulo.
Why it matters
Potential benefit: If successful, the approach could reduce vein recanalization and the need for repeat treatments while improving patients' leg symptoms and quality of life.
How similar studies have gone: Ultrasound-guided foam sclerotherapy is widely used but has higher recanalization rates in larger veins, while mechanochemical ablation has shown lower recanalization in several prior studies though results are not uniformly definitive.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * CEAP Classification C2, 3 or 4 * Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound. Exclusion Criteria: * 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's running
-
Hospital da Clínicas da FMUSP
São Paulo, São Paulo, Brazil Recruiting
Study contacts
- Study coordinator: Antonio Zerati, PhD
- Email: a.zerati@fm.usp.br
- Phone: +5511996354925
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.