A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Intraoperative conversion rate
研究概览
简要总结
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries；
Study purpose：This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Study design：Retrospective + prospective, real-world study
Investigational medical device： English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects should meet all the following criteria:
- •Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic surgeries with the SP single-port robot;
- •Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
排除标准
- •The subjects meeting any of the following criteria should be excluded.
- •Patients with missing data on the primary endpoint in retrospective cases;
- •Subjects having any contraindications of single-port robot surgery;
- •The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- •Patients who are considered inappropriate to participate in this Study by investigators.
结局指标
主要结局
Intraoperative conversion rate
时间窗: Intraoperative
incidence of device-related or likely related complications
时间窗: 30 days
次要结局
- Urethral catheter indwelling duration(up to 4 weeks)
- Intraoperative bleeding volume(Intraoperative)
- The rate of intraoperative blood transfusion(Intraoperative)
- Admission to ICU and ICU LOS(up to 4 weeks)
- Short-term recovery of functions for1 )Erectile function and 2)Urinary continence function(in the follow-up 1 month after the surgery)
- Postoperative pain score(follow-ups 1 day (24±4 hours), 3 days (72±4 hours) and 1 month (30±5 days) after the surgery.)
- Surgical duration(Intraoperative)
- Length of stay (LOS)(up to 4 weeks)