跳至主要内容
临床试验/NCT03326219
NCT03326219撤回不适用

Histopathological Study of the Vena Saphena Magna After Mechanochemical Endoveneous Ablation

Rijnstate Hospital1 个研究点 分布在 1 个国家开始时间: 2017年1月1日最近更新:
适应症
干预措施

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

Other

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

发起方
Rijnstate Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Michel Reijnen

Dr. Michel Reijnen, MD, PI, vascular surgeon

Rijnstate Hospital

研究点 (1)

Loading locations...

相似试验