Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 237
- 试验地点
- 2
- 主要终点
- 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.
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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.
时间窗: 52 weeks
次要结局
- 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)
研究者
RR van den Bos
MD, PhD
Erasmus Medical Center