Loading clinical trials...

RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency | Clinical Trials | Clareo Health

COMPLETEDNA

RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency

Three-year Outcomes of a RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS Study, by the French Society of Phlebology)

NCT05468450•Societe Francaise de Phlebologie

View on ClinicalTrials.gov

Summary

FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.

Detailed Description

Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence. To date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•symptomatic varicose veins (CEAP C2s-C6)
•underlying isolated SSV incompetence (SSV reflux time\>0.5sec on duplex ultrasound (DUS))
•reflux involving at least 15 cm of proximal SSV
•minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position)

Exclusion Criteria

•SSV treatment in the preceding 3 months
•post-thrombotic disease
•deep or superficial vein thrombosis of less than 3 months duration
•coexistent ipsilateral GSV insufficiency
•morbid obesity (BMI\>40)
•presence of significant arterial disease (ABPI\<0.5)

Key Dates

Start Date

July 1, 2015

Primary Completion Date

August 31, 2016

Completion Date

August 31, 2016

Last Updated

July 21, 2022

Enrollment

161

ACTUAL participants

Conditions

Varicose Veins of Lower Limb

Interventions

Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant

DRUG

Endovenous Laser Ablation (EVLA)

DEVICE

Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

NCT06711120

Varicose Veins of Lower LimbVenous Insufficiency of Leg+1 more

View study

RECRUITING

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

NCT06693245

Vascular Disease，PeripheralVenous Insufficiency of Leg+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 21, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency

Inclusion Criteria

Exclusion Criteria

Comparative Analysis of Radiofrequency Ablation and Microwave Ablation Procedures for the Treatment of Small Saphenous Varicose Veins

Observation of Pain During the Treatment of Great Saphenous Vein Using Microwave Ablation， and Analysis of Related Factors

Registry for Chronic Venous Disease Incidence and Natural Course

Effect of Cold Immersion on Patients With Varicose Vein

The Study of Reducing Adverse Effects After Radiofrequency Ablation Combined With Sclerotherapy

Great Saphenous Vein Sparing Segmental Radiofrequency Ablation in Varicose Veins Patients