da Vinci SP Surgical System, Thoracic Surgery
Conditions
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.
Interventions
DEVICEda Vinci SP Surgical System for Single-Port Thoracic Surgeries
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.
Sponsors
Intuitive Surgical
Ruijin Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model 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
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* 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; 2. 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
* 1\. Patients with missing data on the primary endpoint in retrospective cases; 2. Subjects having any contraindications of single-port robot surgery; 3. The intraoperative anatomy determined that minimally invasive surgery was not suitable; 4. Patients who are considered inappropriate to participate in this study by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Intraoperative conversion rate | 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 |
Countries
China
Contacts
Primary ContactHecheng Li
Backup ContactChengqiang Li
Outcome results
None listed