Valuate the Clinical Performance and Safety of da Vinci SP Surgical System

Launched by RUIJIN HOSPITAL · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the safety and effectiveness of a special robotic system called the da Vinci SP Surgical System, which is designed to assist in certain types of chest surgeries. The goal is to gather real-world evidence about how well this system works and how safe it is for patients in China who need surgeries like lung removal or tumor resection. The trial is currently looking for participants to join the study.

To be eligible, participants should be adults who are planning to have specific surgeries using the da Vinci SP robot, and they must agree to take part in the study by signing a consent form. However, certain patients may not qualify, such as those with specific health issues or those for whom the robotic surgery is not suitable based on their individual situation. If someone joins the trial, they can expect to undergo their planned surgery with the robot, and researchers will carefully monitor their health and recovery to collect important data on the system's performance.

Gender

ALL

Eligibility criteria

• 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.