NCT07289295已完成不适用
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Total Hysterectomy
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 3
- 主要终点
- Success rate
研究概览
简要总结
The objective of this clinical trial is to expand the clinical evaluation of the safety and efficacy of Versius in gynaecology procedures of total robotic assisted hysterectomy and/or salpingo-oophorectomy
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female, aged 22 years or above, who provided written informed consent to participate in the study.
- •Patient deemed suitable for minimally invasive total hysterectomy and/or Salpingo-Oophorectomy, for benign condition.
- •Patient with BMI ≤40.
排除标准
- •Patient unwilling to provide informed consent.
- •Medical contraindication for general anaesthesia or minimally invasive procedure.
- •Oncological cases, patient undergoing surgery or treatment for malignant disease.
- •Clinically assessed Uterus size of > 14 pregnancy weeks (Estimated as > 14-15 cm longitudinal diameter).
- •Patient participation in an interventional clinical study that could impact primary outcomes results.
- •Patient who falls into American Society of Anaesthesiologists (ASA) Class IV or above (Appendix A).
- •Uncontrolled hypertension, uncontrolled diabetes mellitus, or kidney failure.
研究组 & 干预措施
Surgery with Versius
Experimental
干预措施: Versius Surgical System (Device)
结局指标
主要结局
Success rate
时间窗: Day of surgery
Rate of successful completion of robotic assisted surgery without unplanned conversion to other laparoscopic or open surgery.
Serious Adverse Event rate
时间窗: Up to 30 days post procedure
Rate of total serious adverse events
次要结局
- Estimated blood loss(Day of surgery)
- Operative time(Day of surgery)
- Intra-operative complications(Day of surgery)
- Blood transfusions(Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)
- Unplanned instrument use(Day of surgery)
- Device deficiencies(Day of surgery)
- Reoperation within 24 hours(24 hours post-surgery)
- Length of hospital stay(Up to post-surgical discharge, i.e. the date when patient is considered sufficiently recovered from surgery to leave hospital, expected to be at most up to 1 month after date of surgery, typically within a few days)
- Adverse events(Up to 30 days post-surgery)
- Readmission(Up to 30 days post-surgery)
- Reoperation within 30 days(Up to 30 days post-surgery)
- Mortality rate(Up to 30 days post-surgery)
- Vaginal vault healing(42 days post-surgery)
研究者
研究点 (3)
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