NCT01717014终止不适用
Evaluating the Radial Reload Stapler With Tri-Staple TM Technology During Open Low Anterior Resection for Rectal Cancer: A Prospective Multicenter Case Series
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 6
- 主要终点
- Staple Line
研究概览
简要总结
The purpose of this research study is to evaluate the safety and feasibility of the Radial Reload Stapler during open LAR for rectal cancer. The surgeon will complete questionnaires relating to the function of the device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is able to understand and sign Informed Consent Form.
- •The subject is between 18-85 years of age.
- •The subject is anticipated to undergo a resection of the rectum with anastomosis below the peritoneal reflection for the treatment of rectal cancer.
- •The subject is anticipated to undergo mobilization and stapling of the rectum through an open incision.
排除标准
- •Any female patient, who is pregnant, suspected pregnant, or nursing.
- •The participant is unable or unwilling to comply with the study requirements, follow-up schedule.
- •The participant has co-morbidities which, in the opinion of the investigator, will not be appropriate for the study.
结局指标
主要结局
Staple Line
时间窗: Operative
The surgeons ability to achieve a staple line at the desired level of the rectum.
Distal Margins
时间窗: Operative
The ability to achieve adequate distal margins (defined as \>2cm \[or \>1cm with clear histologic evaluation\]) in the low rectum.
次要结局
- Usability: Access(Operatively)
- Usability: Visibility(Operatively)
- Usability: Manueverability(Operatively)
研究者
研究点 (6)
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