Actively Recruiting
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
Led by AdventHealth · Updated on 2024-08-20
35
Participants Needed
1
Research Sites
315 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Male or female
- Body mass index (BMI) 26 kg/m2 or less
- ASA score of 3 or less
- Diagnosed with benign disease for cholecystectomy
- Diagnosed with GERD and/or hiatal hernia for fundoplication
- Diagnosed with benign or early malignant stomach disease for gastrectomy
- AJCC 8th edition T0, T1, T2, or T3 stomach tumor pathology (with neoadjuvant therapy if needed)
- Free of metastatic disease for gastrectomy
- Diagnosed with benign or malignant pancreatic disease for distal pancreatectomy
- No vascular involvement for distal pancreatectomy
- Free of metastatic disease for distal pancreatectomy
- Diagnosed with benign or malignant pancreatic or distal bile duct disease for pancreaticoduodenectomy
- No vascular involvement and free of metastatic disease for pancreaticoduodenectomy
- Diagnosed with benign or malignant esophagus disease for esophagectomy
- AJCC 8th edition T0, T1a, T1b, T2 tumor pathology for esophagectomy
- AJCC 8th edition T2, T3, or T4a tumor pathology with neoadjuvant therapy at investigator discretion
- Free of metastatic disease for esophagectomy
- Diagnosed with benign or malignant liver or bile duct disease for hepatectomy
- Free of metastatic disease excluding metastatic disease to the liver for hepatectomy
You will not qualify if you...
- Requiring emergent or emergency operation
- Pregnancy or nursing
- Body mass index (BMI) greater than 26 kg/m2
- Previous abdominal surgery
- Unable to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery
- Malignant disease for cholecystectomy
- Tumor involvement of surrounding vasculature for distal pancreatectomy, pancreaticoduodenectomy, and hepatectomy
- AJCC 8th edition tumor pathology not meeting inclusion criteria for gastrectomy and esophagectomy
- Clinical or radiological evidence of distant metastatic disease
- Perihilar cholangiocarcinoma (Klatskin tumor) for hepatectomy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
AdventhHealth
Tampa, Florida, United States, 33613
Actively Recruiting
Research Team
D
Daniel Robledo, MS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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