NCT02046967

Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 237 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

Detailed description

The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

Conditions

• Varicose Veins
• Varicose Veins of Leg With Long Saphenous Vein Distribution

Interventions

Type	Name	Description
PROCEDURE	Endovenous laser ablation with 940 nm bare fiber	Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
PROCEDURE	Endovenous steam ablation with steam vein sclerosis system.	Endovenous steam ablation with steam vein sclerosis.

Timeline

• Start date: 2009-11-01
• Primary completion: 2013-03-01
• Completion: 2013-03-01
• First posted: 2014-01-28
• Last updated: 2014-01-28

Locations

1 site across 1 country: Netherlands