Skip to content

To evaluate the clinical study on the safety and effectiveness of endoscopic laparoscopy system for thoracic and abdominal surgery

To evaluate the clinical study on the safety and effectiveness of endoscopic laparoscopy system for thoracic and abdominal surgery

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400091497
Enrollment
Unknown
Registered
2024-10-29
Start date
2023-11-10
Completion date
Unknown
Last updated
2024-11-04

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

Conditions

None listed

Interventions

Thoracic and abdominal endoscopic operation group:The abdominal endoscopic surgical system independently developed by Ruilonofu (Shanghai) Medical Technology Co., Ltd. is used for endoscopic surgery i

Sponsors

Affiliated Cancer Hospital of Fudan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)18 years old = age =80 years old, gender is not limited; 2) Plans to perform urology, gynecology, general surgery or thoracic surgery laparoscopic surgery system to assist laparoscopic or thoracoscopic surgery; 3) Agree to participate in this study, and voluntarily sign the informed consent; 4) Willing to cooperate to complete the study follow-up and related examinations.

Exclusion criteria

Exclusion criteria: 1) BMI < 18.5kg/m^2 or BMI=30kg/m^2; 2) Patients with severe cardiovascular diseases who cannot tolerate laparoscopic thoracic surgery; 3) Patients with severe respiratory diseases who cannot tolerate laparoscopic thoracic surgery; 4) Patients with severe coagulation dysfunction who cannot tolerate laparoscopic thoracic surgery; 5) Patients with a history of thoracic, abdominal and pelvic surgery or chemoradiotherapy are not suitable for thoracic laparoscopic surgery; 6) Pregnant and lactating women; 7) Patients who are participating in clinical trials of other drugs or medical devices; 8) Patients considered unsuitable for this study by the investigators.

Design outcomes

Primary

MeasureTime frame
Surgical failure rate;Serious complication rate of surgery;

Secondary

MeasureTime frame
System preparation time;Robot-assisted surgery time;Device performance evaluation;Intraoperative physiological load evaluation by the surgeon during surgery;Evaluation of the mental load of the surgeon during surgery;Postoperative hospital stay;Pain score(efficacy indicator);Intraoperative blood loss;Intraoperative blood transfusion rate;Incidence of device defect;System repairable failure rate;System serious failure rate;Postoperative complication rate;Postoperative readmission rate;Postoperative reoperation rate;Postoperative mortality;Device-related adverse events and serious adverse events;Adverse events and serious adverse events(safety indicator);

Countries

China

Contacts

Public ContactYe Dingwei

Affiliated Cancer Hospital of Fudan University

dwyeli@163.com+86 21 6417 5590

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026