NCT01459263已完成不适用
Mechanochemical Endovenous Ablation of Great Saphenous Vein Incompetence Using the ClariVeinTM Device: a Prospective Study
Rijnstate Hospital2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2010年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 2
- 主要终点
- Occlusion rate
研究概览
简要总结
More than 25 percent of the general population suffers from varicose veins, which has a considerable impact on quality of life. Nowadays endovenous treatment modalities for great saphenous incompetence are widely accepted. Mechanochemical endovenous ablation is a new tumescent-less technique, that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. The current study aims at evaluating short and long term outcome after mechanochemical endovenous ablation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insufficiency of the GSV
- •Ultrasound criteria for endovenous treatment have been met:
- •Diameter GSV between 3-12 mm
- •No thrombus present at the GSV part to be treated
- •Signed informed consent
- •Patient willing to present at follow-up visits
- •Age > 18 jaar
排除标准
- •Patient is unable to give informed consent
- •Patient unable to present at all follow-up visits
- •Other treatment is more suitable for the treatment of the varicose veins than mechano-chemical ablation
- •Pregnancy and breast feeding
- •Known allergy/ contra indication for sclerotherapy
- •Previous ipsilateral surgical treatment of varicose veins
- •Deep venous vein thrombosis in medical history
- •Anticoagulant therapy
结局指标
主要结局
Occlusion rate
时间窗: 30 days, 1, 2, and 5 years
The percentage of GSV occluded
次要结局
- Disease related quality of life(30 days, 1, 2, and 5 years)
- Pain score during procedure(peri-procedural)
- procedural complications(during procedure)
- Health status(30 days, 1, 2, and 5 years)
- 2-weeks post-procedure pain score(two weeks)
- post-procedural complications(1 year)
- recovery time(two weeks)
研究者
Michel Reijnen
MD, PhD
Rijnstate Hospital
研究点 (2)
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