Evaluate the Safety and Effectiveness of the Endoscopic Surgical Instrument Control System (SP1000): a Multi-center, Randomized, Single-blind, Parallel Controlled Clinical Tria
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Surgical success rate
研究概览
简要总结
Robot-assisted surgery has been successfully adopted rapidly over the last decade. Robotic technology with tridimensional imaging can improve operating dexterity, visualization of difficult anatomic locations. This is a prospective study aims to evaluate the safety and effectiveness of the domestic surgical robot.
详细描述
In this clinical trial, the subjects will be randomly divided into two groups, and the urological typical surgical procedures (prostatectomy, and partial or radical nephrectomy) will be performed with the endoscopic surgical instrument control system SP1000 and IS3000.And the non-inferiorly comparison will be made between the surgical results of two systems to verify the safety and effectiveness of the endoscopic surgical instrument control system (SP1000).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female age from 18 to 80
- •BMI 18-30kg/m2
- •Have urological surgery indications (cystectomy, prostatectomy, and nephrectomy)
- •Patients with physiologic conditions capable of receiving laparoscopic surgery
- •Be able to cooperate and complete the follow-up and related examinations
- •Volunteer to participate in this study and sign the informed consen
排除标准
- •The researchers assess patients with severe cardiovascular or circulatory disease and cannot tolerate the surgery
- •History of epilepsy or mental illness
- •Pregnant and lactation
- •Surgery history at the relevant surgical site, which is considered to influence surgical procedures
- •Severe allergic or addiction of drug and alcohol
- •Abdominal infection, peritonitis, diaphragmatic hernia, severe systemic infection or metastasis disease
- •Inability to understand the trial or complete the follow-up
- •Participated in other therapeutic clinical trials within 90 days
- •Patients who had undergone major operation and major trauma within 28 days prior to enrollment, which the researchers considered to have an impact on the outcome of surgery
- •Patients deemed unsuitable to participate in this trial by researchers
结局指标
主要结局
Surgical success rate
时间窗: 24 hours
The surgical success rate was defined as the percentage of patients in the experimental group and the control group who were successfully operated with the systems
Incidence of serious adverse events during clinical trial
时间窗: 3 months
次要结局
- Operative time(12 hours)
- Machine installation time(preoperative)
- Changes in prostate-specific antigen levels(3 months)
- Tumor recurrence rate(3 months)
- Perioperative complication rate(3 months)
- Changes in serum creatinine(3 months)
- Pain after surgery(24 hours)
- Surgeon Satisfaction(12 hours)
- Blood loss during the surgery(12 hours)
- Margin positive rate(1 month)