A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Urological Surgeries

Launched by RUIJIN HOSPITAL · Dec 13, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating the safety and effectiveness of the da Vinci SP Surgical System, which is a robotic tool used for performing single-port surgeries related to urological conditions, like prostate or kidney surgeries. The goal is to gather real-world evidence about how well this robotic system works in patients in China. The study will include both past and current patients who are having or have had these specific types of surgeries.

To join the study, participants must be planning to have or have already had surgeries like prostate removal, kidney removal, or other related procedures using the da Vinci SP robot. They should also be willing to take part and sign a consent form. However, people with certain conditions or previous surgeries that make them unsuitable for robotic surgery will not be included. Those who participate can expect to contribute to valuable research that may help improve surgical techniques and outcomes for future patients.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• Subjects should meet all the following criteria:
• • 1. 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;
• • 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:
• • The subjects meeting any of the following criteria should be excluded.
• • 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 investigators.