Pilot Trial of the Robotic Uterine Manipulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 13
- 主要终点
- the Number of Intraoperative Complications Attributed to the Robotic Manipulator.
研究概览
简要总结
The purpose of this study is to test a robotic uterine manipulator system called the Barakat Automated Uterine Manipulator (BAUM), which will assist the surgeon in moving and positioning the uterus during a hysterectomy. This new device will allow the surgeon to control the movements of the robotic arm directly instead of giving verbal instructions to a staff member. The BAUM has never been used during surgeries before this trial. Overall, the study goal is to determine whether the use of this robotic uterine manipulator system can be safely used in the operating room while improving surgeon control during the procedure.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
- •Female participants must be 18 years of age or older
排除标准
- •Female participant is not eligible if the surgeon does not plan to use a uterine manipulator
结局指标
主要结局
the Number of Intraoperative Complications Attributed to the Robotic Manipulator.
时间窗: 25- 35 days
will be assessed by reporting all intraoperative complications during the surgery. Complications might include vaginal tear or uterine perforation.
次要结局
未报告次要终点