Study of the da Vinci SP Surgical System for Minimally Invasive Hepatopancreaticobiliary and Foregut Surgeries in Adults

What this Trial Is About

Researchers are collecting data to assess the safety and performance of the da Vinci SP Surgical System, Instruments, and Accessories during hepatopancreaticobiliary HPB and foregut surgeries. These surgeries include cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy for both benign and malignant diseases. The study is designed as a prospective, single-center investigation focusing on these procedures. Participants will be grouped into four stages based on their diagnosed condition, with each participant undergoing one surgical operation using the da Vinci SP Single-Port Robotic Surgical System. Stage One includes patients undergoing cholecystectomy or hiatal hernia repair with fundoplication. Stage Two involves gastrectomy or distal pancreatectomy. Stage Three covers pancreaticoduodenectomy or esophagectomy, and Stage Four includes hepatectomy. The robotic system is designed to enable minimally invasive single-port surgery through a surgeon console, vision cart, and patient cart with camera and instruments. During the study, participants will be monitored through various assessments including operative time, blood loss, intraoperative and postoperative complications, physical status, survival, disease recurrence, and readmission rates. Follow-up evaluations occur up to five years to track outcomes such as adverse events, positive resection margins, lymph node yield, and overall survival. Participants are followed closely after surgery through hospital discharge and at scheduled intervals to provide comprehensive safety and performance data for the system.

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease