Histopathological Study of the Vena Saphena Magna After Mechanochemical Endoveneous Ablation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Occlusion of the with Clarivein treated vein
研究概览
简要总结
A new technique, mechanochemical endovenous ablation (MOCA), using the ClariVein ® system is recently developed. To date, histopathological data after mechanochemical endovenous ablation are not known.
The aim of this study is the histopathological analysis of venous injury using mechanochemical endovenous ablation.
详细描述
Background:
Varicose veins are a common problem in the Western world. Epidemiological studies show that one quarter of adults have some form of varicose veins. Women are two to three times more affected than men. The prevalence of varicose veins increases steadily with age and is among the top ten of the complaints that people visit their General Practitioner. The main risk factors are prolonged standing or sitting, pregnancy, gender and age. The symptoms of varicose veins are variable and range from cosmetic complaints to venous ulcers.
Stripping of the great saphenous vein(GSV) has been the golden standard for GSV insufficiency for a long time. It is performed under regional or general anesthesia and has a high recurrence rate of 18-40% at 5 years. In addition, the procedure leads to significant postoperative symptoms, especially pain, hematoma and the risk of injury to the saphenous nerve.
In recent years, endovenous techniques have been developed for the treatment of primary GSV insufficiency. Particularly laser endovenous ablation (EVLA) and radiofrequency ablation (VNUS) became accepted technologies and are widely applied in practice. These thermal-based techniques have the advantage that the surgery can be performed with local anesthesia. In addition, endovenous techniques cause less hematoma, pain, and have superior cosmetics and earlier resumption of normal activities/work compared to the conventional surgical stripping.
Endothermal techniques use heat, which has potential risk to damage surrounding tissues. For this reason, patients are treated with tumiscence anesthesia, requiring multiple punctures around the vein. Most patients experience tumiscence anesthesia as unpleasant. Despite the tumiscence anesthesia, patients may still observe postoperative pain, which may last for weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •Elective indication for leg amputation
- •Peripheral arterial disease
- •Age > 18 years
- •Written informed consent
排除标准
- •Patient is incapable of informed consent
- •Pregancy and lactation
- •Previous surgical or endovenous treatment of the greater saphenous vein in the amputed leg
- •Great saphenous vein is used for bypass surgery
研究组 & 干预措施
Aethoxysklerol clarivein during leg amp
Clarivein treatment with Aethoxysklerol in 5 patients during lower or upper leg amputation
干预措施: Clarivein (Procedure)
结局指标
主要结局
Occlusion of the with Clarivein treated vein
时间窗: 2 years of inclusion and analyzation
Occlusion of the with the Clarivein (Aethoxysklerol) treated vein, check wheter or not treatment was succesfull.
Depth of damage inside and/or outside the venous wall
时间窗: 2 years of inclusion and analyzation
Depth of damage inside and/or outside the venous wall is to check whether or not the venous wall is damaged due to the Clarivein treatment
次要结局
- Analysis of intraluminal clot / scar(2 years of inclusion and analyzation)
- Morphological changes of the saphenous nerve due to damage of treatment(2 years of inclusion and analyzation)
- Perivascular damage resulting from treatment(2 years of inclusion and analyzation)
研究者
Michel Reijnen
Dr. Michel Reijnen, MD, PI, vascular surgeon
Rijnstate Hospital
