European Sapheon™ Closure System Observational ProspectivE (eSCOPE) Study (eSCOPE)
2016年4月29日 更新者：Medtronic Endovascular
Post Market Study - "European Observational Study of the Sapheon™ Closure System for the Definitive Treatment of Incompetent Great Saphenous Veins: A Prospective Single Arm Multicenter Clinical Observational Study"
The primary objective for this clinical study is to assess the role of the CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
研究概览
详细说明
This is a post market, observational study of closure of the great saphenous vein "GSV".
Efficacy and safety (adverse events) will be compared to appropriate literature reports to determine if the results of the treatment of reflux disease with the Sapheon Closure System are consistent with or better than the expectations of the medical community for alternative treatments, specifically Laser Thermal Ablation and Radiofrequency Ablation.
Additional comparison points may include measurements of pain and/or length of time to return to work.
研究类型
介入性
注册 (实际的)
70
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Naestved、丹麦、4700
- Aareknudeklinikken
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Hamburg、德国、20354
- Dermatologikum
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Mannheim、德国、D - 68161
- Klinik Proebstle
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Chester、英国、CH2 1UL
- COUNTESS OF CHESTER HOSPITAL NHS FOUNDATION TRUST
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Guildford、英国、GU2 7RF
- The Whiteley Clinic
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London、英国、W6 8RF
- Charing Cross Hospital
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Alkmaar、荷兰
- Centrum Oosterawal
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Age ≥18 years and ≤ 70 years of age.
- Symptomatic primary Great Saphenous Vein "GSV" incompetence diagnosed by clinical symptoms, with or without visible varicosities, and confirmed by duplex ultrasound imaging.
- CEAP classification of C2, C3 or C4.
- Ability to walk unassisted.
- Ability to attend follow-up visits.
- Ability to understand the requirements of the study and to provide written informed consent.
- "GSV" on standing pre-procedure Doppler Ultrasound ≥3mm and ≤10mm (maximum diameter).
Exclusion Criteria:
- Life expectancy < 1 year.
- Regular pain medication.
- Anticoagulation including Heparin or Coumadin.
- Previous Deep Vein Thrombosis "DVT".
- Previous superficial thrombophlebitis in "GSV".
- Previous venous treatment on target limb.
- Known Hyper-coagulable disorder.
Conditions which prevent routine vein treatment like:
- Acute disease,
- Immobilization or inability to ambulate, and
- Pregnancy.
- Tortuous "GSV", which in the opinion of the Investigator will limit catheter placement. (no 2 primary access sites allowed).
- Incompetent ipsilateral small saphenous or anterior accessory great saphenous vein.
- Known sensitivity to the cyanoacrylate "CA" adhesive.
- Current participation in another clinical study involving an investigational agent or treatment, or within the 30 days prior to enrollment.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：CE Marked Sapheon Closure System in GSV
CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
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CE Marked Sapheon Closure System in closure of incompetent great saphenous veins "GSV" in a routine clinical setting.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Comparative Duplex Ultrasound
大体时间：Immediately Post-procedure
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The Primary endpoint is a change in duplex ultrasound immediately post-procedure as compared to the pre-procedure duplex ultrasound, proving great saphenous vein closure with lack of pathological reflux.
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Immediately Post-procedure
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Safety
大体时间：Immediately post-op through 6 month Follow-up "FU"
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The Secondary endpoint is safety, reflected by the rate of occurrence of all adverse events (procedure and non-procedure related; serious and non-serious).
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Immediately post-op through 6 month Follow-up "FU"
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Thomas Proebstle, MD、Klinik Proebstle
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Proebstle T, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Davies AH. Three-year follow-up results of the prospective European Multicenter Cohort Study on Cyanoacrylate Embolization for treatment of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2021 Mar;9(2):329-334. doi: 10.1016/j.jvsv.2020.05.019. Epub 2020 Jun 26.
- Proebstle TM, Alm J, Dimitri S, Rasmussen L, Whiteley M, Lawson J, Cher D, Davies A. The European multicenter cohort study on cyanoacrylate embolization of refluxing great saphenous veins. J Vasc Surg Venous Lymphat Disord. 2015 Jan;3(1):2-7. doi: 10.1016/j.jvsv.2014.09.001. Epub 2014 Oct 18.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2011年12月1日
初级完成 (实际的)
2013年7月1日
研究完成 (实际的)
2015年9月1日
研究注册日期
首次提交
2012年3月26日
首先提交符合 QC 标准的
2012年3月30日
首次发布 (估计)
2012年4月4日
研究记录更新
最后更新发布 (估计)
2016年5月3日
上次提交的符合 QC 标准的更新
2016年4月29日
最后验证
2016年4月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.