ISRCTN36582296已完成未知
A prospective, non-randomised, open-label, multicenter safety study of Neucrylate AN™ Liquid Embolic System for the treatment of cerebral berry aneurysms
Valor Medical Inc. (USA)0 个研究点目标入组 40 人开始时间: 2009年10月6日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Subject must be a male or female >=18 years of age (i.e., not children as defined by local law or regulation)
- •2. Subject must have a cerebral aneurysm and neurological status
- •3. Subject must be considered by the physician to be available for subsequent visits
- •4. Subject must be able to comply with all aspects of the treatment and evaluation schedule over 7 months duration
- •5. Subject must sign and date an EC/IRB-approved written informed consent prior to initiation of any study procedures, including screening procedures (if unable to sign for self, where applicable, legal representative may do so)
- •6. Subject has not previously been treated for aneurysm or subarachnoid haemorrhage
排除标准
- •1. Subject is female and pregnant, or breastfeeding
- •2. Subject has a known allergy to cyanoacrylates
- •3. Subject has a significant bleeding disorder
- •4. Subject has known hypersensitivity to any component of the study device or procedural materials
- •5. Subject is concurrently involved in another investigational study
- •6. Subject has received any investigational product within 30 days prior to entry into this trial
- •7. Subject has an acute life-threatening illness other than the neurological disease to be treated in this trial
- •8. Inability to obtain valid informed consent (consent may be given by legal representative, where applicable)
- •9. Subject has a life expectancy of less than 1 year due to other illness or condition (in addition to aneurysm)
- •10. The subject requires treatment for fusiform or lateral aneurysm
研究者
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