Varicose Veins Clinical Trials

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

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 4
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• CEAP Classification C2, 3 or 4

• Insufficient great saphenous vein measuring 6-12 mm in the mid-thigh on Doppler ultrasound.

Locations
Other Locations
Brazil
Hospital da Clínicas da FMUSP
RECRUITING
São Paulo
Contact Information
Primary
Antonio Zerati, PhD
a.zerati@fm.usp.br
+5511996354925
Time Frame
Start Date: 2026-05
Estimated Completion Date: 2027-11
Participants
Target number of participants: 50
Treatments
Active_comparator: Great saphenous vein insufficiency (1)
25 limbs with great saphenous vein insufficiency
Experimental: Great saphenous vein insufficiency (2)
25 limbs with great saphenous vein insufficiency
Related Therapeutic Areas
Sponsors
Leads: Antonio Eduardo Zerati

This content was sourced from clinicaltrials.gov