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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
237
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
Endovenous steam ablation with steam vein sclerosis.
Erasmus MC
Rotterdam, Netherlands
Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.
Time frame: 52 weeks
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Time frame: 12 weeks
Minor complications: ecchymosis, pain and hyperpigmentation.
Time frame: 12 weeks
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Time frame: 12 weeks
Treatment satisfaction
Time frame: 2 weeks
Pain score
Time frame: 2 weeks
Venous Clinical Severity Score (VCSS)
Time frame: 12 weeks
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