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

NCT07530133 | Not Yet Recruiting DMC

• 1 other identifier: WJ251117
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 3

Brief 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

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

Keywords

Pediatric surgery; Minimally invasive surgery

Outcome Measures

Primary Outcomes (2)

• Rate of non-conversion to open or conventional laparoscopic surgery

  Intraoperative

• Incidence of device-related or possibly related Clavien-Dindo Grade ≥3 complications from first incision to 30 days postoperatively

  From first incision up to 30 days postoperatively

Secondary Outcomes (7)

• 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

Study Arms (1)

Experimental

EXPERIMENTAL

All subjects receive surgical treatment using the thoracic and abdominal endoscopic surgery system (Model WJ-SR01-200)

Device: Thoracic and Abdominal Endoscopic Surgery System

Interventions

Thoracic and Abdominal Endoscopic Surgery System DEVICE

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

Experimental

Eligibility Criteria

• Age: 0 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hangzhou Kangji Weijing Medical Robotics Co., Ltd.: lead
• Wuhan Children's Hospital: collaborator
• The Children's Hospital of Zhejiang University School of Medicine: collaborator
• Second Affiliated Hospital of Wenzhou Medical University: collaborator

Study Sites (3)

Wuhan Children's Hospital

Wuhan, Hubei, 430016, China

Location

The Children's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310052, China

Location

The Second Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325027, China

Location

Central Study Contacts

Gao Zhi Gang

CONTACT

13958154777; ebwk@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Single-group, target-value design without a control group or blinding. All eligible subjects receive the investigational thoracic and abdominal endoscopic surgery system. No randomization is used.

Study Record Dates

• First Submitted: March 31, 2026
• First Posted: April 15, 2026
• Study Start: April 9, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)