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

Summary

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.

Conditions

• Indications for Laparoscopic Thoracic and Abdominal Surgery in Children
• Congenital or Acquired Surgical Conditions Requiring Minimally Invasive Surgery in Children
• Pyeloplasty
• Ureteral Reimplantation
• Ovarian Tumor Resection
• Radical Operation for Hirschsprung Disease
• Fundoplication
• Pulmonary Segmentectomy
• Choledochal Cyst Resection

Interventions

DEVICE

Thoracic and Abdominal Endoscopic Surgery System

A master-slave robotic surgical system (Model WJ-SR01-200) consisting of a surgeon console, patient surgery platform, endoscopic image processor, 3D electronic endoscope, surgical instruments and accessories. It is used to perform minimally invasive thoracic and laparoscopic procedures in pediatric patients aged 0 to \<18 years

Sponsors & Collaborators

• Wuhan Children's Hospital

  collaborator OTHER

• Second Affiliated Hospital of Wenzhou Medical University

  collaborator OTHER

• The Children's Hospital of Zhejiang University School of Medicine

  collaborator OTHER

• Hangzhou Kangji Weijing Medical Robotics Co., Ltd.

  lead INDUSTRY

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

0 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-04-09

Primary Completion

2026-10-31

Completion

2026-10-31

Countries

• China

Study Locations