A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Thoracic Surgeries
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- da Vinci SP Surgical System
- Sponsor
- Ruijin Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Intraoperative conversion rate
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted thoracic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Detailed Description
Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects who have received or plan to receive pulmonary lobectomy/segmentectomy, mediastinal tumor resection (including thymectomy), radical resection of esophagus cancer or other surgeries with the SP single-port robot;
- •Patients who voluntarily decide to participate in the study and sign the ICF (or exempt from signature of the ICF as approved by the EC).
Exclusion Criteria
- •Patients with missing data on the primary endpoint in retrospective cases;
- •Subjects having any contraindications of single-port robot surgery;
- •The intraoperative anatomy determined that minimally invasive surgery was not suitable;
- •Patients who are considered inappropriate to participate in this study by investigator.
Outcomes
Primary Outcomes
Intraoperative conversion rate
Time Frame: intraoperative
Intraoperative conversion rate = number of subjects with intraoperative conversion/total number of subjects ×100%. The intraoperative conversion is defined as conversion to other procedures (including but not limited to traditional laparoscopic surgeries, other robot-assisted surgeries, open surgeries and so on) for various reasons during surgery