BridgeMD
New treatment option for Hepatopancreaticobiliary and Foregut Operations
Official title A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
ClinicalTrials.gov ID: NCT06562179
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Cholecystectomy Stage 1 -
- Patients between the ages of 18 and 80 years of age
- Either male or female
- BMI ≤ 26 kg/m2
- ASA ≤ 3
You likely can't join if
- Cholecystectomy Stage 1- Exclusion Criteria:
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI \> 26 kg/m2
- Previous abdominal surgery
- people with malignant disease
See the full eligibility criteria
Who can join
- 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)
What rules you out
- Cholecystectomy Stage 1- Exclusion Criteria:
- Subject requiring an emergent operation
- Pregnancy or nursing
- BMI \> 26 kg/m2
- Previous abdominal surgery
- people with malignant disease
- Inability to provide informed consent
- Contraindicated for general anesthesia or minimally invasive surgery Fundoplication Stage 1- Exclusion Criteria:
- 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 Gastrectomy Stage 2- Exclusion Criteria:
- 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 Distal Pancreatectomy Stage 2- Exclusion Criteria:
- 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 Pancreaticoduodenectomy Stage 3- Exclusion Criteria:
- 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 Esophagectomy Stage 3- Exclusion Criteria:
- 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 Hepatectomy Stage 4- Exclusion Criteria:
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Tampa, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tampa, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.