Hysteroscopic Intrauterine Suturing by Using X-Tack - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.
研究概览
简要总结
Clinical trial The aim of the study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack, inserted into the uterus by hysteroscope.
Primary outcome:
Intrauterine suture will sustain the procedure - when the uterus will be opened the suture will be observed.
Secondary outcome:
Procedure complications. Study Design Interventional pilot Study
Study group:
Women undergoing laparoscopic hysterectomy.
详细描述
Introduction:
A hysteroscopy is a procedure used to examine and treat the inside of the uterus.
Apollo X-tack is an endoscopic apparatus for stomach defect closure by gastroscopy.
The aim of this study is to evaluate the safety and feasibility of intrauterine suturing with Apollos X-tack inserted into the uterus by hysteroscope.
Study Design Interventional pilot study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Benign indication for hysterectomy
排除标准
- •Evidence or suspicious for malignancy
结局指标
主要结局
Device Feasibility (intrauterine suturing) - The suture will sustain inside the uterus.
时间窗: Immediately after the procedure.
When the uterus will be opened the suture will be observed.
次要结局
- Safety: Procedure complications - Uterine perforation, vaginal\cervical\uterine injury.(Immediately after the procedure.)