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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-17
SponsorHangzhou Kangji Weijing Medical Robotics Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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

Treatment groups

64 Participants
are divided into 1 treatment group
Group A: ExperimentalExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Rate of non-conversion to open or conventional laparoscopic surgery

Time frame
Intraoperative
2

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

Time frame
From first incision up to 30 days postoperatively

Secondary outcomes

1

Operation time

Time frame
Intraoperative
2

Estimated intraoperative blood loss (mL)

Time frame
Intraoperative
3

Pediatric pain score

The scale used is the Neonatal Postoperative Pain Score(The total score is 10 points: \>3 points indicates mild pain, 4-6 points indicates moderate pain, and 7-10 points indicates severe pain)、Children's Pain Behavior Scale(There are five evaluation criteria, with a total score ranging from 0 to 10: 0 indicates no pain; 1-3 indicates mild pain; 4-6 indicates moderate pain; and 7-10 indicates severe pain)、Revised Wong-Baker Facial Pain Rating Scale(Cartoon images depicting six facial expressions (ranging from smiling and sad to crying in agony) are provided to visually represent the pain intensity corresponding to each score range)

Time frame
Postoperative 24±4 hours or prior to discharge
4

Transfusion rate

Time frame
Intraoperative

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hangzhou Kangji Weijing Medical Robotics Co., Ltd.

Lead sponsor

Wuhan Children's Hospital

Collaborator

Second Affiliated Hospital of Wenzhou Medical University

Collaborator

The Children's Hospital of Zhejiang University School of Medicine

Collaborator

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