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Clinical research on the safety and effectiveness of the thoracoabdominal endoscopic surgical instrument control system for endoscopic surgery

Clinical research on the safety and effectiveness of the control system for thoracic and abdominal endoscopic surgical instruments and the surgical instruments used in thoracic and abdominal endoscopic surgery systems for endoscopic surgery.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600120176
Enrollment
Unknown
Registered
2026-03-10
Start date
2026-03-13
Completion date
Unknown
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None

Interventions

Single-group test:Surgery and operation

Sponsors

Children's Hospital,Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age less than 18 years old, gender not restricted; 2. Patients with acceptable physical conditions for common laparoscopic surgeries in pediatric surgery, including but not limited to general surgical laparoscopic surgeries (such as choledochal cyst surgery, radical resection of megacolon, abdominal tumor resection, etc.) and urological laparoscopic surgeries (such as pyeloureteral anastomosis, nephrectomy, repeated kidney resection, bladder ureteral reimplantation, etc.); 3. Voluntary to participate in clinical research, and willing to sign the informed consent form with their own consent or with the consent of their guardians; 4. Willing to cooperate in completing the research follow-up and related examinations.

Exclusion criteria

Exclusion criteria: 1. Patients who cannot tolerate surgery, such as those with congenital heart disease or lung diseases; 2. Patients who cannot tolerate anesthesia and pneumoperitoneum; 3. Patients who are not suitable for laparoscopic surgery (such as severe abdominal adhesions, etc.);3) Patients who are not suitable for laparoscopic surgery (such as severe abdominal adhesions, etc.); 4. Patients with a history of bleeding disorders or hematopoietic dysfunction or coagulation disorders; 5. Patients with a history of radiotherapy or chemotherapy and are not suitable for laparoscopic surgery; 6. Patients who are participating in other clinical trials of drugs or medical devices; 7. Other situations that the investigator deems unsuitable for participating in this trial.

Design outcomes

Primary

MeasureTime frame
Incidence of severe complications;The non-conversion rate of the surgery;

Secondary

MeasureTime frame
Robot-assisted surgery time;Intraoperative blood transfusion rate;Intraoperative blood loss;System preparation time;The rate of system repairable faults;The incidence of postoperative readmission;The occurrence of adverse events and serious adverse events;Incidence of device defects;Postoperative mortality rate;Incidence of postoperative complications;Pain score;Evaluation of device performance;Evaluation of the mental load of the chief surgeon in the surgical center;The occurrence of adverse events and serious adverse events related to the device;The incidence of reoperation after surgery;The incidence rate of serious system failures;Evaluation of the intraoperative physiological load of the chief surgeon;Postoperative hospital stay days;

Countries

China

Contacts

Public ContactZhigang Gao

Children's Hospital,Zhejiang University School of Medicine

ebwk@zju.edu.cn+86 571 86670011

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Mar 20, 2026