Compression Anastomosis Using the CAR™ 27
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc
研究概览
简要总结
Purpose:
Evaluation of the CAR™ 27 for the creation of compression anastomoses.
Indication:
Compression Anastomosis Ring (CAR™ 27) device for creation of circular anastomoses during colonic or colorectal resection.
Study Design:
Prospective, open labeled study.
Patient Population:
Male or female subjects 18 years of age or older who are scheduled for non emergency laparoscopic or open colonic or colorectal resections. A temporary loop ileostomy/colostomy can be preformed up to the discretion of the surgeon.
No. of Subjects:
15 patients estimated up to three months to enroll.
Duration of Treatment:
During the operation - creation of the anastomosis.
Duration of Follow-up:
Follow-up evaluation will be performed daily while hospitalized, during a post-op clinic visit at approximately 1 month (30 days ± 5 days) including a proctoscopic exam and by phone after 3 months.
Endpoints:
To evaluate the creation of a safe and functioning anastomosis and the occurrence of adverse events related to the use of the CAR™ 27 device.
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 over 18 years old.
- •Patient is scheduled for a non-emergency procedure.
- •Subject signs and dates a written informed consent form (ICF) and indicates an understanding of the study procedures.
排除标准
- •Patient has an allergy to nickel.
- •Patient has a diagnosis of bowel obstruction, bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, carcinomatosis or extensively spread inflammatory bowel disease.
- •Patient is 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
Complications during and post procedure including leaks, bleeding, strictures, device failure, re admission, re operation, extra colonic complications etc
时间窗: 3-months
次要结局
未报告次要终点