Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Success rate in performing an operation with at least one OR person less
研究概览
简要总结
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the AutoLap system compared with the standard operation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Aged ≥ 18 years
- •Able to provide a written informed consent
排除标准
- •Obesity (BMI >35 Kg/m2)
- •Contra-indications for performing laparoscopy
研究组 & 干预措施
Control Group
Patients in this group will undergo an elective standard laparoscopic procedure with a designated OR staff to maneuver the laparoscopic camera. The procedures will be performed according to the hospital and OR routine procedure.
AutoLap Group
Patients in this group will undergo a laparoscopic procedure using the AutoLap system. In this group the surgeon will use the AutoLap system to hold and control the movements of the laparoscopic camera.
干预措施: AutoLap system (Device)
结局指标
主要结局
Success rate in performing an operation with at least one OR person less
时间窗: During surgery
次要结局
- Duration of the operation(During surgery)
- Number of times the laparoscope is removed for cleaning(During surgery)
- Usability evaluation(Up to two days post surgery)