NCT07530133Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 15 Apr 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 64 (estimated)
- First submitted
- 31 Mar 2026
- Start date
- 9 Apr 2026
- Primary completion date
- 31 Oct 2026
- Lead sponsor
- Hangzhou Kangji Weijing Medical Robotics Co., Ltd.
- Diseases
- Ovarian cancer, Childhood cancers
- NCT number
- NCT07530133
What you commit to
- Study type: Interventional
- Planned participants: 64
- From 9 Apr 2026 to the primary completion date, 31 Oct 2026
- 3 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous laparoscopic or open surgery at the target site, deemed unsuitable for laparoscopic surgery by the investigator.
- Suspected or confirmed drug addiction.
- 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 illness
- Thoracic/abdominal/pelvic infection, peritonitis, diaphragmatic hernia, or severe systemic infection, deemed unsuitable for laparoscopic surgery.
- Severe cardiovascular or circulatory disease incompatible with surgery.
- Epilepsy or cognitive impairment.
- Other conditions deemed unsuitable by the investigator.
Lab values
- 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).
Other
- Pregnancy.
Who the study is looking for
- 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.
Age in the registry: 0 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Children's Hospital, Zhejiang University School of Medicine Coordinator of this site? Confirm its status | Hangzhou | China | Unknown status |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Unknown status |
| Wuhan Children's Hospital Coordinator of this site? Confirm its status | Wuhan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.