NCT07316517尚未招募不适用
Prospective Clinical Study to Evaluate the Safety and Efficacy of Versius in Robot-Assisted Inguinal Hernia Repair Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Success rate
研究概览
简要总结
The objective of this clinical trial is to evaluate the safety and efficacy of Versius in Inguinal Hernia repair surgery
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
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients 22 years of age and older, deemed eligible for elective minimal invasive inguinal Hernia repair surgery.
- •Patients providing written informed consent to participate in the study.
排除标准
- •Patient unwilling to provide informed consent.
- •Medical contraindication for general anaesthesia or minimally invasive procedure.
- •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.
- •Patients undergoing a concomitant surgical procedure.
- •Contraindication for undergoing surgery with Versius (bleeding diathesis, active pregnancy or BMI ≥40 kg/m2).
结局指标
主要结局
Success rate
时间窗: Up to completion of surgery
Rate of successful completion of robotic assisted surgery as planned 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 procedure related serious adverse events
次要结局
- Intra-operative adverse events(Up to completion of surgery)
- Blood transfusion(Up to completion of surgery)
- Device deficiencies(Up to completion 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)
- Operative time(Up to completion of surgery)
- Estimated blood loss(Up to completion of surgery)
- Adverse events(Up to 30 days post-surgery)
- Reoperation within 30 days(Up to 30 days post-surgery)
- Readmission(Up to 30 days post-surgery)
- Mortality rate(Up to 30 days post-surgery)
研究者
研究点 (1)
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