Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- Erasmus Medical Center
- Enrollment
- 237
- Locations
- 1
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief 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.
Investigators
RR van den Bos
MD, PhD
Erasmus Medical Center
Eligibility Criteria
Inclusion Criteria
- •Patients over 18 years old
- •Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 s, and diameter of vein \> 0.5 cm
- •Symptoms of chronic venous insufficiency
- •No prior treatment of the insufficient GSV
- •Informed consent
Exclusion Criteria
- •Acute deep or superficial vein thrombosis
- •Agenesis of deep vein system
- •Vascular malformation or syndrome
- •Post-thrombotic syndrome, occlusive type
- •Pregnancy
- •Immobility
- •Allergy to lidocaine
- •Arterial insufficiency
Outcomes
Primary Outcomes
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
Secondary Outcomes
- Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.(12 weeks)
- Minor complications: ecchymosis, pain and hyperpigmentation.(12 weeks)
- Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).(12 weeks)
- Treatment satisfaction(2 weeks)
- Pain score(2 weeks)
- Venous Clinical Severity Score (VCSS)(12 weeks)