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

Study 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.

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

Conditions
-----------------
Varicose Veins, Varicose Veins of Leg With Long Saphenous Vein Distribution

Intervention / Treatment
-----------------
* Procedure: Endovenous laser ablation with 940 nm bare fiber
* Procedure: Endovenous steam ablation with steam vein sclerosis system.


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Endovenous laser ablation<br>Endovenous laser ablation with 940 nm bare fiber. | Procedure: Endovenous laser ablation with 940 nm bare fiber<br>* Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.<br>* Other names: EVLA;|
| Active Comparator: Endovenous steam ablation<br>Endovenous steam ablation with steam vein sclerosis system. | Procedure: Endovenous steam ablation with steam vein sclerosis system.<br>* Endovenous steam ablation with steam vein sclerosis.<br>* Other names: EVSA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life