NCT00671203已完成3 期
Prevention of Colon Ischemia During Aortic Aneurysm (AAA) Repair
Spectros Corporation4 个研究点 分布在 1 个国家目标入组 500 人开始时间: 2007年6月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Detect colon ischemia early
研究概览
简要总结
Patients undergoing surgery on their Aorta can get ischemia, a lack of blood flow, to their intestines and colon. This is very serious, as 2 out of 3 patients who have this problem die before leaving the hospital. A device developed by Spectros, called T-Stat, is approved by the US FDA to detect ischemia, and has been reported to detect ischemia in AAA aneurysm surgery and stenting, allowing the surgeon or interventional radiologist to take action quickly, while the colon ischemia is still treatable.
This purpose of this study is to establish how T-Stat can best be used to prevent deaths.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aortic Aneurysm, intact or ruptured
- •Repair by catheter based stent or by open surgery during monitoring
- •Patent rectum
- •Absence of rectal bleeding
排除标准
- •Lack of informed consent
- •Rectal bleeding
- •Obstructed rectum
结局指标
主要结局
Detect colon ischemia early
时间窗: Just before, and during, surgery or stenting
次要结局
- Allows change in the untreated course of colon ischemia(28 days or discharge from hospital)
研究者
研究点 (4)
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