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

NCT05468450 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 161

Last updated 2022-07-21

No results posted yet for this study

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.

Conditions

  • Varicose Veins of Lower Limb

Interventions

DRUG

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

Direct injection Foam sclerotherapy

DEVICE

Endovenous Laser Ablation (EVLA)

EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)

Sponsors & Collaborators

  • Societe Francaise de Phlebologie

    lead OTHER

Principal Investigators

  • Claudine Hamel-Desnos · Institut des Varices- GHPJS Groupe Hospitalier

  • Matthieu Josnin · Société Française de Phlébologie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-07-01
Primary Completion
2016-08-31
Completion
2016-08-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05468450 on ClinicalTrials.gov