A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Thoracic Surgeries
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Ruijin Hospital
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Intraoperative conversion rate
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Arm 1
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.
Intervention: da Vinci SP Surgical System for Single-Port Thoracic Surgeries (Device)
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
Secondary Outcomes
No secondary outcomes reported