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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400085091
Enrollment
Unknown
Registered
2024-05-30
Start date
2024-05-30
Completion date
Unknown
Last updated
2024-06-03

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

Conditions

patients undergoing laparoscopic surgery

Interventions

experimental group:endoscopic laparoscopy surgery system

Sponsors

Fujian Medical University Union Hospital
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 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/m2 or BMI=30kg/m2; 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;

Secondary

MeasureTime frame
System preparation time; robot-assisted surgery time; instrument performance evaluation; intraoperative physiological load evaluation; intellectual load evaluation of surgical center; postoperative hospital stay; pain score;Intraoperative blood loss; Intraoperative blood transfusion rate; incidence of instrument defect; incidence of repairable system failure; incidence of serious system failure;incidence of postoperative complications; incidence of postoperative readmission; incidence of postoperative reoperation; postoperative mortality; incidence of device-related adverse events and serious adverse events; Adverse events and serious adverse events;

Countries

China

Contacts

Public Contactchen chun

Fujian Medical University Union Hospital

chenchun0209@163.com+86 133 6591 0325

Outcome results

None listed

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