NCT04109989Unknown不适用
Clinical Assessment - HominisTM Surgical System
Memic Innovative Surgery3 个研究点 分布在 2 个国家目标入组 50 人开始时间: 2018年11月8日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 3
- 主要终点
- Rate of conversion
研究概览
简要总结
A clinical research study designed to assess the HominisTM Surgical System in gynecological procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 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 above 18 years of age inclusive.
- •Able to provide written informed consent.
- •Eligible for Total Transvaginal Laparoscopic Hysterectomy with Salpingo-Oophorectomy or Transvaginal Laparoscopic Hysterectomy with Salpingectomy and have an appropriate indication to go through this surgery.
- •Willing to undergo laparoscopic transvaginal procedure by Memic HominisTM Surgical System.
- •Fit for robotic-assisted transvaginal surgery based on surgeon discretion.
- •Can undergo general anesthesia per anesthesiologist assessment.
排除标准
- •Women with anatomical hazard for laparoscopy and/or vaginal and/or pouch of Douglas access (such as diagnosis of Crohn's disease, active Pelvic inflammatory disease (PID), active diverticulitis, sever peritoneal adhesions, frozen pelvis, obliterated vagina or sever recto-vaginal endometriosis).
- •Women after pelvic radiation.
- •Women diagnosed with active intra-abdominal malignancy.
- •Women with general condition or illness incompatible for surgery.
- •Women who are pregnant.
- •Unwillingness or inability to follow the procedures outlined in the protocol.
结局指标
主要结局
Rate of conversion
时间窗: Intra Operative
Rate of conversion to open or laparoscopic approach
次要结局
- Vaginal tissue healing(Six weeks post procedure)
- Intra-operative & post-operative procedural outcomes(Intra-operative & six weeks post procedure)
- Intra-operative procedural outcomes(Intra-operative)
- Post-operative procedural outcomes(Six weeks post procedure)
研究者
研究点 (3)
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