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da Vinci SP® Surgical System for Hepatopancreaticobiliary and Foregut Operations

This study is looking at the safety and effectiveness of the da Vinci SP® Surgical System, a robotic system that helps surgeons perform operations through a single small incision. It's being used for operations on the liver, pancreas, and bile ducts (hepatopancreaticobiliary) and the upper digestive tract (foregut operations), including procedures like gallbladder removal (cholecystectomy) and surgery for heartburn (fundoplication). The study plans to enroll 35 participants aged 18 to 80. Doctors will be looking to see if the surgery can be completed using the da Vinci SP system, and they will track any problems during or after surgery, as well as how much cancerous tissue is left behind after surgery (positive resection margins). The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 35 participants. It is a single-center investigation.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for adverse events and positive resection margins for up to 24 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06562179

A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease

Recruiting
NAAges 18–80InterventionalTreatment
AdventHealth
~35 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:da Vinci SP® Single-Port Robotic Surgical System

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Completion Using the planned da Vinci SP-assisted Single Port Robot.
Measured over 12 months
+3 more outcomes measured

Conditions

Hepatopancreaticobiliary and Foregut Operations

Explore related trials

Bile Duct CarcinomaCholecystectomyEsophageal CarcinomaGastric CarcinomaGastroesophageal Reflux DiseaseHiatal HerniaLiver CarcinomaPancreatic Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Study leadership

  • Sharona Ross, MD · PRINCIPAL_INVESTIGATOR · AdventHealth

Who to contact

Daniel Robledo, MS
[email protected]
8139716000 · ext. 56518
Email the study team

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Completion Using the planned da Vinci SP-assisted Single Port Robot.12 months

    The number of subjects who completed the planned da Vinci SP-assisted operation without conversion to an alternate approach. Conversion to an alternate approach comprises conversion to open, multiport laparoscopic, multiport robotic or hand-assisted approach requiring undocking of the da Vinci SP Surgical System in order to complete the planned operation using the alternate approach.

  • Intraoperative and post-operative adverse events24 months

    The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period.

  • Number of Positive resection Margins24 months

    Number of positive resection margins in patients with Malignant disease.

  • Number of Lymph node yield24 Months

    Number of lymph node yield in patients with Malignant disease.