Clinical Trial on Safety and Efficacy of Thoracoabdominal Endoscopic Surgical System for Pediatric Surgery

Prospective, Multicenter, Single-arm Target-value Clinical Trial Evaluating the Safety and Efficacy of Thoracoabdominal Endoscopic Surgical Systems in Pediatric Surgery

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.

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.

The primary efficacy endpoint is the rate of non-conversion from the investigational robotic system to open surgery or conventional laparoscopic surgery. The primary safety endpoint is the incidence of device-related or possibly device-related Clavien-Dindo Grade ≥3 complications from the first incision up to 30 days postoperatively.

Secondary outcome measures include operation time, estimated intraoperative blood loss, transfusion rate, length of hospital stay, post-operative pain scores, device performance, and surgeon intraoperative physical discomfort using a dedicated questionnaire. Additional safety assessments include overall complication rate (Clavien-Dindo Grade ≥1), device deficiency rate, 30-day readmission rate, 30-day reoperation rate, 30-day mortality rate, changes in vital signs, laboratory abnormalities, adverse events (AEs), and serious adverse events (SAEs).

All adverse events and device deficiencies will be monitored, recorded, and reported in compliance with regulatory requirements. Serious adverse events will be reported to the sponsor, ethics committee, and relevant regulatory authorities within the required timeframes.

The trial uses a single-arm target-value design without a control group or blinding. Sample size was calculated based on the primary efficacy and safety endpoints in accordance with the Technical Review Guidelines for Abdominal Endoscopic Surgery Systems (2023 Revision). A target sample size of 64 subjects was determined to account for a dropout rate of approximately 15%.

Statistical analysis will be performed using SAS software (version 9.4 or higher). Efficacy analyses will be conducted using the Full Analysis Set (FAS) and Per-Protocol Set (PPS). Safety analyses will be performed using the Safety Analysis Set (SS). Descriptive statistics will be used for demographic and baseline characteristics. Proportions will be summarized with frequencies and percentages, and continuous variables with mean, standard deviation, median, and range. The 95% confidence intervals will be calculated for primary endpoints to test whether the study meets predefined clinical performance goals.

The trial will be conducted at multiple registered clinical research institutions. The principal investigator at the lead center is responsible for overall study conduct, data quality, and compliance with the protocol. Site personnel will be trained on the protocol, device operation, and GCP prior to study initiation. Regular monitoring will be performed to ensure adherence to the protocol, accurate data collection, and proper management of the investigational device.

Written informed consent will be obtained from the legally authorized representative of each subject before any study-related procedures. Assent will be obtained from subjects who are developmentally capable of participating in the decision. The study protocol has been approved by the independent ethics committee/institutional review board of each participating institution.

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.