Efficacy and Safety of MP1000 System in Remote and Local Liver Surgery: A Prospective, Multicenter, Single-blind, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Surgical success rate
研究概览
简要总结
The goal of this clinical trial is to learn if the robotic surgical system producted by Shenzhen Edge Medical Company has a non-inferior textbook outcome in liver surgery in the field of remote surgery compared to local robotic surgery. It will also learn about the safety of remote liver surgery.
The main questions are: Does remote liver surgery not lower the textbook outcomes in liver surgery compared to the local robotic surgery? What complications do participants have when taking remote liver surgery? Investigators will compare remote liver surgery to local robotic liver surgery to see if remote liver surgery doesn't lower the textbook outcome in liver surgery.
Participants will:
Undergo remote or local robotic liver surgery according to the random program; Visit the clinic in 3, 28 and 42 day after surgery for checkups and tests; Keep a diary of their postoperative complications.
详细描述
(1) Background
Surgery is an important mean to treat diseases. In recent years, surgical techniques have been developing, evolving from initial open surgery and minimally invasive laparoscopic surgery to current robotic surgery. Surgical robotic systems have been applied in clinical practice for over 20 years and got many excellent results. Compared to traditional laparoscopic surgery, robotic surgery show the following advantages:
- Provide the surgeons with high-definition and three-dimensional views;
- The surgical instruments can simulate the flexibility of human fingers and eliminate unnecessary tremors;
- Surgeons use the control consoles to operate devices like open surgery, which doesn't require long-term learning and training;
- The surgeons can independently control the endoscopes and surgical instruments, reducing the need of surgical team members and making it easier to achieve the surgeons' intentions;
- The surgeons operate the systems in sitting positions, which is more easy to perform complex and long time surgery and prolongs the surgeons' surgical life;
- Patients benefit greatly from this new surgical method for smaller incisions, shorter recovery time, and fewer hospital days.
Shenzhen Edge Medical Company has solved many core technologies of robotic surgical system (such as master-slave control strategies, kinematics research, multi-degree-of-freedom simulation manipulators and stereoscopic vision). Beijing Medical Device Inspection Institute has completed the product performance inspection and safety inspection for MP1000 system.
MP1000 system has completed clinical trials for urology, gynecology, general surgery and thoracic surgery, with a 100% success rate in surgeries. Currently, MP1000 system has been approved by the National Medical Products Administration (NMPA). Edge Cloud® remote surgery system also had approved by NMPA in November 2025, with the registration number of 20253011753.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range: 18-75 years old (inclusive), gender not restricted;
- •BMI: 18-30 Kg/m2;
- •Relevant indications for liver surgery;
- •Physiological condition allows for laparoscopic surgery, and the Iwate score for laparoscopic difficulty of the enrolled patients is ≤ 6;
- •Willing to cooperate and complete follow-up and related subsequent examinations;
- •Voluntary to sign the informed consent form;
- •Indocyanine green 15-minute retention rate (ICG-R15) < 15%, and liver function Child-Pugh grade is A.
排除标准
- •Patients with severe circulatory system diseases who cannot tolerate surgery;
- •Pregnant or lactating women;
- •Patients with a history of epilepsy or mental illness;
- •Patients with severe allergic constitution and those suspected or diagnosed with alcohol or drug addiction;
- •Patients who cannot understand the research requirements or who cannot complete the research follow-up;
- •Patients considered unsuitable to participate in this trial by the researchers.
研究组 & 干预措施
Local Surgery
The patients in this arm (group) will undergo local liver surgery according to random allocation.
干预措施: Local Liver Surgery (Device)
Remote Surgery
The patients in this arm (group) will undergo remote liver surgery according to random allocation.
干预措施: Remote Liver Surgery (Device)
结局指标
主要结局
Surgical success rate
时间窗: 6 weeks
The number of subjects who successfully completed remote surgical treatment using the experimental equipment, as a proportion of the total number of subjects. The definition of a successful surgery: (a) The surgical process was completed according to the original plan; (b) There was no conversion of surgical methods, such as remote-local, remote-laparoscopic/open; (c) There was no delay due to failure of the surgical system. Whether each case was successful should be confirmed by the medical team after the surgery based on the pre-set criteria for judgment.
The incidence rate of complications of grade 3 and above
时间窗: 6 weeks
The number of subjects who experienced complications of grade 3 or above, as a proportion of the total number of subjects. Definition: The incidence rate of complications that are definitely or possibly related to the device and meet the Clavien-Dindo classification system criteria of grade 3 or above from the first incision to 6 weeks after the surgery. The complication grade is from 1 to 5. The higher grade means a worse result. Grade 1: Any deviation from the normal postoperative course without need for pharmacological treatment or surgical, endoscopic, or radiological interventions. Grade 2: Complications requiring pharmacological treatment other than those allowed in Grade I, including blood transfusions and total parenteral nutrition. Grade 3: Complications requiring surgical, endoscopic, or radiological intervention. Grade 4: Life-threatening complications requiring intermediate care (IC) or intensive care unit (ICU) management. Grade 5: Death of a patient.
次要结局
- Incidence of adverse events(6 weeks)
- Console Time(During surgery)
- Blood loss(During surgery)
- Incidence of serious adverse events(6 weeks)
- Positive Margin rate(In one week after surgery)
- Incidence of device defects(6 weeks)
- Overall complication rate(6 weeks)
- Operation Time(During surgery)
- Patient pain score(6 weeks)
- Doctor satisfaction(1 week)
- Postoperative hospital stay(4 weeks)
- Blood transfusion rate(6 weeks)
- Readmission rate(6 weeks)
- Reoperation rate(6 weeks)
- Mortality(6 weeks)
- Remote operation evaluation(In one week after surgery.)
研究者
Chen Xiaoping
Chief of Surgery
Tongji Hospital