A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.
The purpose of this study is to collect data to evaluate safety and performance of the da Vinci SP Surgical System, Instruments and Accessories in hepatopancreatic biliary (HPB) and Foregut operations. HPB and Foregut operations of this study consist of cholecystectomy, fundoplication, gastrectomy, distal pancreatectomy, pancreaticoduodenectomy, esophagectomy, and hepatectomy.
⁃ Cholecystectomy Stage 1 - Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either male or female
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign disease
⁃ Fundoplication Stage 1- Inclusion Criteria:
• Patients diagnosed with GERD and/or hiatal hernia
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
⁃ Gastrectomy Stage 2- Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign or relatively early malignant disease of the stomach
• AJCC 8th edition T0 or T1 tumor pathology
• AJCC 8th edition T2, T3, tumor pathology (following neoadjuvant therapy if necessary) at the discretion of the investigator
• Free of metastatic disease
⁃ Distal Pancreatectomy Stage 2- Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign or malignant disease of the pancreas
• No vascular involvement
• Free of metastatic disease
⁃ Pancreaticoduodenectomy Stage 3- Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign or malignant disease of the pancreas
• Diagnosed with benign or malignant distal bile duct disease
• No vasculature involvement (i.e., no T4 disease, pancreatic or Stage 4a or b disease, or distal bile duct Stage 3b or 4 disease)
• Free of metastatic disease
⁃ Esophagectomy Stage 3- Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign or malignant disease of the esophagus
• AJCC 8th edition T0, T1a, T1b, T2 (without other indications for neoadjuvant therapy) tumor pathology
• AJCC 8th edition some T2, T3, or T4a, (following neoadjuvant therapy) at the discretion of the investigator
• Free of metastatic disease
⁃ Hepatectomy Stage 4- Inclusion Criteria:
• Patients between the ages of 18 and 80 years of age
• Either men or women
• BMI ≤ 26 kg/m2
• ASA ≤ 3
• Diagnosed with benign or malignant disease of the liver or bile duct
• Free of metastatic disease, not including metastatic disease to the liver (e.g., colorectal liver metastases)