Overview
Study name:A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries;
Study purpose: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 urological robotic surgeries in the real world, providing a real world evidence for clinical application of the product in the Chinese population.
Study design:Retrospective + prospective, real-world study
Investigational medical device: English name: da Vinci SP Surgical System Model and specification: SP1098 Manufacturer: Intuitive Surgical, Inc.
Eligibility
Inclusion Criteria:
Subjects should meet all the following criteria:
- Subjects who have received or plan to receive RP, PN, RN, radical resection of the renal pelvic carcinoma (one position), pyeloplasty and other single-port urological robotic 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:
The subjects meeting any of the following criteria should be excluded.
- 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 investigators.