ACTRN12619000536167已完成未知
A Prospective, Single-arm, Multicenter Study to Evaluate the Safety and Performance of the Instylla Hydrogel Embolic System (HES) For Patients Requiring Vascular Embolization Alone or in the Pre-operative Setting for Treatment of Malignant and Benign Hypervascular Tumors, and Select Non-Traumatic End-Organ Infarct.
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- Instylla Inc
- 入组人数
- 8
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •1. Male or female patients age greater than or equal to 18 years old
- •2. Embolization of hypervascular lesion is clinically indicated
- •3. Expected life expectancy greater than or equal to 6 months after embolization
排除标准
- •1. Ongoing adverse effect that may confound the evaluation of the Instylla HES
- •2. Pregnant or breast-feeding, or females planning on becoming pregnant within the next 6 month
- •3. The patient has other concurrent conditions that in the opinion of the Investigator would be unlikely to receive clinical benefit from the study procedure or participation in the study may compromise patient safety or study objectives (including but not limited to ongoing infection, renal dysfunction, morbid obesity)
研究者
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