Status:
RECRUITING
A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
Lead Sponsor:
AdventHealth
Conditions:
Hepatopancreaticobiliary and Foregut Operations
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Cholecystectomy Stage 1 -
- 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-
- 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-
- 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-
- 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-
- 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-
- 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-
- 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 Criteria
- Cholecystectomy Stage 1-
Exclusion
- 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
- Fundoplication Stage 1-
Key Trial Info
Start Date :
May 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2030
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT06562179
Start Date
May 14 2024
End Date
June 1 2030
Last Update
August 20 2024
Active Locations (1)
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1
AdventhHealth
Tampa, Florida, United States, 33613