Post Market Study: Use of the Reusable FloShield 10mm Endoscopic Cannula and Blunt Obturator and the Robotic FloShield System During Robot-assisted Laparoscopic Single-Site Surgery. A Multicenter Historical Control Comparison
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Completion rate
研究概览
简要总结
This study evaluates the use of the FloShield System with the FloShield 10mm reusable Cannula and Oburator during standard robotic laparoscopic single-site surgery. The study will evaluate the compatibility of the FloShield 10mm Cannula and Oburator with the daVinci® Robotic Surgical System during single-site laparoscopic surgery.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
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
- •Male or female, 18 years or older
- •Scheduled for a laparoscopic single-incision surgery for cholecystectomy, benign hysterectomy or salpingo-oophorectomy under the care of the study investigator
- •Suitable candidate for surgery
- •Is able to read and understand the informed consent form and has voluntarily provided written informed consent
排除标准
- •Unfit for surgery: concomitant disorders incompatible with the study or surgery (at the discretion of the investigator)
- •Subjects with known allergy (hypersensitivity) to Docusate Sodium
- •Use of Surgiquest AirSeal during the laparoscopic single-site surgery
- •Use of humidified insufflation
结局指标
主要结局
Completion rate
时间窗: 1 - 4hr (Initial insertion to final withdrawal of the laparoscope)
Completion rate is the percentage of users who successfully complete the task without critical errors. A critical error is defined as an error that results in an incorrect or incomplete outcome (Grade 1 and 2). In other words, the completion rate represents the percentage of participants who, when they are finished with the specified task, have an "output" that is correct (Grade 3 - 5). Note: If a participant requires assistance in order to achieve a correct output then the task will be scored as a critical error and the overall completion rate for the task will be affected. A completion rate of 90% is the goal for each task in this usability test.
次要结局
- Performance(1 - 4hr (Initial insertion to final withdrawal of the laparoscope))