Pilot Trial of YUMI Uterine Manipulator
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 13
- 主要终点
- number of successfully placed Uterine Manipulator
研究概览
简要总结
The purpose of this study is to test the feasibility and safety of using a new device called Yukio's Uterine Manipulating Instrument (YUMI). The YUMI is a type of uterine manipulator. It is a reusable metal device designed to be simple and study. It is also adjustable in size which makes it easy for surgeons to use. It will be placed at the beginning of the surgery and removed at the end. This study will allow the researchers to find out if the surgeons find the YUMI effective and easy to use. It will also allow the researchers to see if the device is safe. This is the first time that the YUMI is being used in humans.
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
- •Participant must be scheduled for a total laparoscopic or robotic-assisted hysterectomy for a gynecologic condition
- •Participants must be 18 years of age or older
排除标准
- •Participant is not eligible if the surgeon does not plan to use a uterine manipulator
结局指标
主要结局
number of successfully placed Uterine Manipulator
时间窗: 1 year
The YUMI manipulator will be considered successfully placed when the device is inserted into the uterus and secured in place to hold for the duration of the procedure.
次要结局
未报告次要终点