RecruitingNot ApplicableNCT06562179
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.
Sponsor
AdventHealth
Enrollment
35 participants
Start Date
May 14, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Min Age: 18 YearsMax Age: 80 Years
Inclusion Criteria47
- 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
- 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
- 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
- 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
- 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
- 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
- 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)
Exclusion Criteria55
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Subjects with malignant disease
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- AJCC 8th edition T2, T3, T4a, T4b tumor pathology (without neoadjuvant therapy unless contraindicated)
- Clinical or radiological evidence of distant metastatic disease
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Tumor involvement with surrounding vasculature (e.g., common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Clinical or radiological evidence of metastatic disease
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Tumor involvement with surrounding vasculature (e.g., T4a for pancreatic disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Tumor involvement with surrounding vasculature (e.g., T3b for bile duct disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)
- Clinical or radiological evidence of metastatic disease
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- AJCC 8th edition T2 (in some circumstances), T3, and T4a tumor pathology (without neoadjuvant therapy)
- Clinical or radiological evidence of distant metastatic disease
- Subject requiring an emergency operation
- Pregnancy or nursing
- BMI > 26 kg/m2
- Previous abdominal surgery
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Perihilar cholangiocarcinoma (i.e., Klatskin tumor)
- Involvement of major vasculature (ex: portal vein, hepatic artery, or inferior vena cava)
- Clinical or radiological evidence of metastatic disease
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Interventions
DEVICEda Vinci SP® Single-Port Robotic Surgical System
The da Vinci SP® Surgical System is designed to enable the performance of surgical procedures using a minimally invasive single-port approach. The system consists of a Surgeon Console, a Vision Cart, and a Patient Cart and is used with a camera, instruments, and accessories.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06562179