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临床试验/NCT02416830
NCT02416830Unknown不适用

Worldwide Therapeutic Embolization Cohort Post Market Registry

EmboCoH1 个研究点 分布在 1 个国家目标入组 250 人开始时间: 2014年4月最近更新:
适应症

试验速览

阶段
不适用
发起方
EmboCoH
入组人数
250
试验地点
1
主要终点
Technical Success (Yes or No)

研究概览

简要总结

The purpose of this cohort post market registry is to collect data and create a global database on use of embolization devices and embolization procedures outcome. The data collected in the cohort will serve a scientific purpose to acquire better insight in embolization procedures. This will be achieved by publications in Scientific Journals and by presentations at scientific meetings. Additionally it will support the industry on creating a better overview of the products used to maintain and enhance the clinical efficacy of the used devices. The cohort post market registry represents a novel approach in a way of allowing Clinicians to generate reports based on an evolving controlled and well organized database

详细描述

INTRODUCTION

Purpose:

The purpose of this cohort post market registry is to collect data and create a global database on use of embolization devices and embolization procedures outcome. The data collected in the cohort will serve a scientific purpose to acquire better insight in embolization procedures. This will be achieved by publications in Scientific Journals and by presentations at scientific meetings. Additionally it will support the industry on creating a better overview of the products used to maintain and enhance the clinical efficacy of the used devices. The cohort post market registry represents a novel approach in a way of allowing Clinicians to generate reports based on an evolving controlled and well organized database.

Hypothesis:

Transcatheter Embolization is a recognized primary treatment of various diseases and a viable alternative to existing treatment options. Further that the Registry will foster generation of Consensus Treatment Documents for the benefit of the Clinicians involved in Transcatheter Embolization. Further that the Registry will increase the level of Transcatheter Embolization as a function of Clinicians getting access to data generated in the Registry.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Eligible for Embolization and willing to sign Data protection form if required

排除标准

  • 未提供

结局指标

主要结局

Technical Success (Yes or No)

时间窗: Assessed within 15 minutes after intervention on the basis of control angiography

Technical success is defined as occlusion of the target area

次要结局

  • Society of Interventional Radiology Classification System for Complications by Outcome - referred to as "SIR Category" (A/B/C/D/E/F)(Assessed within 15 minutes after intervention on the basis of control angiography)
  • Occlusion of Aneurysm (Yes or No or Partial)(Assessed within 15 minutes after intervention on the basis of control angiography)
  • Immediate Angiographic Complications ('Yes' or 'No'(Assessed within 15 minutes after intervention on the basis of control angiography)

研究者

发起方
EmboCoH
申办方类型
Other
责任方
Sponsor

研究点 (1)

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