NCT01056796Unknown2 期
Compression Anastomosis For Low Anterior Resection in Previously Radiated Patients Using the CAR™ 27
Niti Medical Technologies Ltd.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2010年1月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
研究概览
简要总结
The purpose of this study is:
Evaluation of the safety and effectiveness of the Compression Anastomosis Ring (CAR™ 27) device for creation of circular, colorectal anastomoses in previously radiated patients.
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
- 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 is ≥ 18 years old.
- •Patient is scheduled for a non-emergency TME and low anterior resection (< 10cm from the anal verge).
- •Patient has been radiated to the pelvic area 6-8 weeks prior to the study.
- •Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
排除标准
- •Patient has known allergy to nickel.
- •Patient undergoing an emergency procedure or has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or inflammatory bowel disease.
- •Patients are participating in another clinical trial which may affect this study's outcomes.
- •Patient has been taking regular steroid medication.
- •Patient has contraindications to general anesthesia.
- •Patient has preexisting sphincter problems or evidence of extensive local disease in the pelvis.
结局指标
主要结局
To evaluate for the occurrence of adverse events related to the use of the CAR™ 27 device, include anastomotic leak, bleeding, ring evacuation and strictures at 6 months.
时间窗: Approx. 1 year
次要结局
- Evaluation of the creation of a functioning CAR™ 27 anastomosis in radiated patients(Approx. 1 year)
研究者
研究点 (1)
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