NCT00468416Unknown2 期
Evaluation of NiTi Shape Memory End-to-End Compression Anastomosis Ring (CAR) for Compression Anastomosis in Anterior Resection
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functioning anastomosis and 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
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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 years
- •Patient scheduled for colorectal cancer surgery
- •Patient is able to comprehend and sign the Informed Consent Form
排除标准
- •Patient has known allergy to nickel
- •Patient with bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection
- •Patients who are participating in another trial
- •Patient on regular steroid medication
- •Patients who are undergoing a stoma
- •Patients with contraindications to general anesthesia
- •Patient with preexisting sphincter problems or evidence of extensive local disease in the pelvis
- •Patients after radiation
- •Patients who refuse consent
结局指标
主要结局
Functioning anastomosis and no occurrence of adverse events related to device use
时间窗: During hospitalization and one month post procedure
次要结局
未报告次要终点
研究者
研究点 (1)
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