Prospective, Multicenter, Single-arm Target-value Clinical Trial Evaluating the Safety and Efficacy of Thoracoabdominal Endoscopic Surgical Systems in Pediatric Surgery
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 3
- 主要终点
- Rate of non-conversion to open or conventional laparoscopic surgery
研究概览
简要总结
This is a prospective, multi-center, single-arm, target-value clinical trial conducted to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (model WJ-SR01-200) in pediatric surgical procedures. A total of 64 pediatric subjects aged 0 to <18 years who meet the indications for thoracic and abdominal laparoscopic surgery will be enrolled. The system is used to perform typical pediatric surgeries including pyeloplasty, ureteral reimplantation, ovarian tumor resection, radical resection of Hirschsprung disease, fundoplication, segmental lung resection, and choledochal cyst resection. The primary efficacy endpoint is the rate of non-conversion to open or conventional laparoscopic surgery.The primary safety endpoint is the incidence of device-related or possibly related Clavien-Dindo Grade ≥3 complications from the first incision up to 30 days postoperatively. Secondary assessments include operation time, estimated intraoperative blood loss, pediatric pain scores, transfusion rate, length of hospital stay, device performance, and surgeon intraoperative physical load. Safety is also evaluated by overall complication rate, device deficiency rate, 30-day readmission/reoperation/mortality rates, vital signs, laboratory tests, and adverse events. The trial follows the Declaration of Helsinki and relevant Good Clinical Practice (GCP) guidelines. All subjects will provide written informed consent from legal guardians; assent will be obtained from subjects when appropriate.
详细描述
This is a prospective, multi-center, single-arm, target-value clinical trial designed to evaluate the safety and effectiveness of the Thoracic and Abdominal Endoscopic Surgery System (Model WJ-SR01-200) when used in pediatric surgical procedures. The trial is conducted in accordance with the Declaration of Helsinki, relevant Good Clinical Practice (GCP) requirements, and applicable regulatory guidelines.
The investigational device is a master-slave robotic surgical system that includes a surgeon console, patient surgery platform, endoscopic image processor, 3D electronic endoscope, surgical instruments, and accessories. It is intended to facilitate precise, minimally invasive thoracoscopic and laparoscopic procedures in pediatric patients.
A total of 64 subjects aged 0 to less than 18 years will be enrolled. Eligible subjects must have clinical indications for thoracic or abdominal laparoscopic surgery and be medically suitable for minimally invasive surgery. Key exclusion criteria include previous surgery at the target site that may preclude laparoscopic intervention, uncontrolled systemic infection, severe coagulopathy, severe cardiovascular instability, epilepsy, cognitive impairment, drug addiction, pregnancy, and recent participation in other interventional clinical trials.
During the study, eligible subjects will undergo surgery using the investigational Thoracic and Abdominal Endoscopic Surgery System. The surgical procedures include pyeloplasty, ureteral reimplantation, ovarian tumor resection, radical resection of Hirschsprung disease, fundoplication, segmental lung resection, choledochal cyst resection, and other representative pediatric laparoscopic procedures.
The study consists of a screening period (within 14 days before surgery), an intraoperative assessment, an in-hospital follow-up, and a 30-day post-operative follow-up. Clinical evaluations include vital signs, routine blood tests, liver and kidney function tests, coagulation function, infectious disease serology, imaging examinations as clinically indicated, and age-appropriate pediatric pain assessments including CRIES, FLACC, and FPS-R scales.
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
- 0 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 0 to 18 years old (excluding 18 years old), gender is not restricted.
- •Subjects with indications for pediatric thoracic and abdominal laparoscopic surgery and medically fit for laparoscopic procedures.
- •Legally authorized representative provides written informed consent; subject assent is obtained when the subject is developmentally capable.
排除标准
- •Previous laparoscopic or open surgery at the target site, deemed unsuitable for laparoscopic surgery by the investigator.
- •Thoracic/abdominal/pelvic infection, peritonitis, diaphragmatic hernia, or severe systemic infection, deemed unsuitable for laparoscopic surgery.
- •Severe bleeding tendency or coagulopathy (APTT > 1.5× upper limit of normal); long-term use of anticoagulants or antiplatelet agents, or such medications not discontinued for at least 1 week preoperatively (prophylactic low-molecular-weight heparin excluded).
- •Severe cardiovascular or circulatory disease incompatible with surgery.
- •Epilepsy or cognitive impairment.
- •Suspected or confirmed drug addiction.
- •Pregnancy.
- •Participation in another interventional device clinical trial within 1 month or a drug clinical trial within 3 months prior to enrollment.
- •Intraoperative findings that preclude laparoscopic surgery (e.g., severe adhesions, anatomical variation, poor exposure).
- •Other conditions deemed unsuitable by the investigator.
研究组 & 干预措施
Experimental
All subjects receive surgical treatment using the thoracic and abdominal endoscopic surgery system (Model WJ-SR01-200)
干预措施: Thoracic and Abdominal Endoscopic Surgery System (Device)
结局指标
主要结局
Rate of non-conversion to open or conventional laparoscopic surgery
时间窗: Intraoperative
Incidence of device-related or possibly related Clavien-Dindo Grade ≥3 complications from first incision to 30 days postoperatively
时间窗: From first incision up to 30 days postoperatively
次要结局
- Operation time(Intraoperative)
- Estimated intraoperative blood loss (mL)(Intraoperative)
- Pediatric pain score(Postoperative 24±4 hours or prior to discharge)
- Transfusion rate(Intraoperative)
- Length of hospital stay(Before discharge)
- Device performance evaluation(Postoperative within 24 hours)
- Surgeon intraoperative physical load(Postoperative within 24 hours)