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

NCT07561320 | Recruiting Phase 4

• 1 other identifier: 83198024.0.0000.0068
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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 Lower Limb; Varicose Veins of Leg With Long Saphenous Vein Distribution

Keywords

Mechanical chemical ablation; Flebogrif; Sclerotherapy with polidocanol foam

Outcome Measures

Primary Outcomes (3)

• Quality Of Life Score: Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire

  Brazilian Version Adapted from the Aberdeen Varicose Veins Questionnaire will be used. Score from 0 to 100, where 0 is the best and 100 is the worst quality of life related to varicose veins.

  From enrollment to the end of treatment at 365 days after procedure

• Disease Severity Score: Venous Clinical Severity Score (VCSS)

  Venous Clinical Severity Score (VCSS) will be used. Score from 0 to 30, where 0 means asymptomatic patient and 30 means more symptomatic patient as possible.

  From enrollment to the end of treatment at 365 days after procedure

• Ultrasound Assessment: Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006

  Classification of the Second European Consensus Meeting on Foam Sclerotherapy Held in Tegernsee, Germany in 2006, will be used. Classification where 0 means reflux greater than 1 second, 1 means reflux less than 1 second, and 2 means no reflux.

  From enrollment to the end of treatment at 365 days after procedure

Secondary Outcomes (2)

• Treatment complications

  One to 365 after procedure

• Pain Level During Procedure: Visual Analog Pain Scale

  Pain level during the procedure

Study Arms (2)

Great saphenous vein insufficiency (1)

ACTIVE COMPARATOR

25 limbs with great saphenous vein insufficiency

Device: Flebogrif; Drug: Polidocanol foam sclerotherapy

Great saphenous vein insufficiency (2)

EXPERIMENTAL

25 limbs with great saphenous vein insufficiency

Device: Flebogrif; Drug: Polidocanol foam sclerotherapy

Interventions

Flebogrif DEVICE

Mechanical-chemical ablation is a technique for treating varicose veins that combines mechanical damage to the venous endothelium with chemical damage using polidocanol foam.

Great saphenous vein insufficiency (1); Great saphenous vein insufficiency (2)

Polidocanol foam sclerotherapy DRUG

Polidocanol foam is a drug infused into varicose veins, causing chemical damage to the endothelium.

Great saphenous vein insufficiency (1); Great saphenous vein insufficiency (2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Antonio Eduardo Zerati: lead

Study Sites (1)

Hospital da Clínicas da FMUSP

São Paulo, São Paulo, Brazil

RECRUITING

Related Publications (4)

• Epstein D, Onida S, Bootun R, Ortega-Ortega M, Davies AH. Cost-Effectiveness of Current and Emerging Treatments of Varicose Veins. Value Health. 2018 Aug;21(8):911-920. doi: 10.1016/j.jval.2018.01.012. Epub 2018 Mar 15.

  PMID: 30098668 BACKGROUND

• Petrone A, Peluso A, Ammollo RP, Turchino D, Del Guercio L, Andreucci M, Serra R, Bracale UM. Selective crossectomy combined with mechanochemical ablation in the treatment of great saphenous vein insufficiency: Early results of a single center experience. Phlebology. 2022 Aug;37(7):522-528. doi: 10.1177/02683555221092194. Epub 2022 Apr 25.

  PMID: 35466820 BACKGROUND

• Whing J, Nandhra S, Nesbitt C, Stansby G. Interventions for great saphenous vein incompetence. Cochrane Database Syst Rev. 2021 Aug 11;8(8):CD005624. doi: 10.1002/14651858.CD005624.pub4.

  PMID: 34378180 BACKGROUND

• Nicolaides AN, Allegra C, Bergan J, Bradbury A, Cairols M, Carpentier P, Comerota A, Delis C, Eklof B, Fassiadis N, Georgiou N, Geroulakos G, Hoffmann U, Jantet G, Jawien A, Kakkos S, Kalodiki E, Labropoulos N, Neglen P, Pappas P, Partsch H, Perrin M, Rabe E, Ramelet AA, Vayssaira M, Ioannidou E, Taft A. Management of chronic venous disorders of the lower limbs: guidelines according to scientific evidence. Int Angiol. 2008 Feb;27(1):1-59. No abstract available.

  PMID: 18277340 BACKGROUND

Central Study Contacts

Antonio Zerati, PhD

CONTACT

+5511996354925; a.zerati@fm.usp.br

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This is a prospective, randomized clinical trial including 50 patients with primary varicose veins and great saphenous vein (GSV) insufficiency (6-12 mm diameter, CEAP C2-C4). Patients will be randomized into two groups: ultrasound-guided foam sclerotherapy (Group 1) and mechanochemical ablation with the Flebogrif® catheter (Group 2).

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: May 1, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

BR (1)