NCT00497263已完成2 期
End-to-End Compression Anastomosis for Left-sided Colectomy Endo-CAR Study
Niti Medical Technologies Ltd.2 个研究点 分布在 1 个国家开始时间: 2007年7月6日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 试验地点
- 2
- 主要终点
- functioning anastomosis & no occurrence of adverse events related to device use
研究概览
简要总结
the purpose of this study is to evaluate the safety and effectiveness of the Niti CAR-device in the creation of colorectal anastomosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient age over 18
- •Patient schedule for colonic surgery requiring E-t-E anastomosis
- •Patient is able to understand and to sign the Informed Consent Form
排除标准
- •Patient has known allergy to Nickel
- •Patient with bowel obstruction, strangulation, peritonitis, perforation, local or systemic infection
- •Patient on regular steroid medication
- •Patient with preexisting sphincter problems or evidence of extensive local disease of the pelvis
- •Patient following radiation (that compromised the anastomosis)
- •Patient who are undergoing a defunctioning stoma
- •Patient with contraindication to general anesthesia
- •Patient who is currently participating in other clinical trial
- •Patient who refuse consent
结局指标
主要结局
functioning anastomosis & no occurrence of adverse events related to device use
时间窗: during hospitalization and until 3 months after discharge
次要结局
未报告次要终点
研究者
研究点 (2)
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