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| Name | Class |
|---|---|
| Intuitive Surgical | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| da Vinci SP Surgical System for Single-Port Thoracic Surgeries | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative conversion rate | 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 | intraoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hecheng Li | Contact | +862164370045 | lhc11863@rjh.com.cn | |
| Chengqiang Li | Contact | 13524282905 | lcq12305@rjh.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 200000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40658465 | Derived | Li C, Chen X, Wang X, Guo W, Zhang Y, Chen F, Li H. Single-Port Robotic-Assisted Approach in Thoracic Surgery: A Prospective Real-World Study. Interdiscip Cardiovasc Thorac Surg. 2025 Jul 3;40(7):ivaf161. doi: 10.1093/icvts/ivaf161. |
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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
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