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

June 9, 2026 updated by: Sharona B. Ross, MD, AdventHealth

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Florida
      • Tampa, Florida, United States, 33613
        • Recruiting
        • AdventhHealth
        • Principal Investigator:
          • Sharona Ross, MD
        • Sub-Investigator:
          • Iswanto Sucandy, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria

Cholecystectomy Stage 1 - Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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- Inclusion Criteria:

  • 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 Criteria:

  • 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- 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: da Vinci SP® Single-Port Robotic Surgical System

This study will be separated into four stages, depending on the condition the participant is diagnosed with. Each Participant will go through (1) one operation.

Stage One will include five (5) subjects who undergo cholecystectomy and five (5) subjects who undergo hiatal hernia repair with fundoplication (Nissen or Toupet) for a total of ten (10) subjects.

Stage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects.

Stage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects.

Stage Four will include five (5) subjects who undergo hepatectomy
Device: da 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion Using the planned da Vinci SP-assisted Single Port Robot.
Time Frame: 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.
12 months
Intraoperative and post-operative adverse events
Time Frame: 24 months
The incidence of all intraoperative and post-operative adverse events that occur through the 24-month follow-up period.
24 months
Number of Positive resection Margins
Time Frame: 24 months
Number of positive resection margins in patients with Malignant disease.
24 months
Number of Lymph node yield
Time Frame: 24 Months
Number of lymph node yield in patients with Malignant disease.
24 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Status Classification
Time Frame: Pre-Operative Visit

Assessment of the fitness of patient before surgery using the ASA Physical Status Score:

Class I - A patient in normal health Class II - A patient with mild systemic disease resulting in no functional limitations Class III - A patient with severe systemic disease that limits activity, but is not incapacitating Class IV - A patient with severe systemic disease that is a constant threat to life Class V - A moribund patient not likely to survive without the operation Class VI - A patient already declared brain dead whose organs are being removed for donor purposes
Pre-Operative Visit
Charlson Comorbidity Index Score
Time Frame: Pre-Operative Visit

Predicts one-year mortality for patients with a range of comorbid conditions, helping the physician determine how aggressively to treat a condition.

This index score is assessed by assigning points (1,2,3 or 6) based on the likelihood of dying associated to 17 different conditions (co-morbidities). Scores are summed to provide a total score to predict mortality. Comorbidity classification is categorized as low (score ≤ 3), moderate (score 4 and 5), high (score 6 and 7), and very high comorbidity (score ≥ 8)
Pre-Operative Visit
Operative Time
Time Frame: Intraoperative
Measured in minutes
Intraoperative
Estimated blood loss
Time Frame: Intraoperatively
Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.
Intraoperatively
Intraoperative complications
Time Frame: Intraoperatively
Incidence rate - number of intraoperatively complications during surgery.
Intraoperatively
Postoperative complications
Time Frame: 10 day, 2 months post surgery
Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery.
10 day, 2 months post surgery
Post surgery complications
Time Frame: 2 months post surgery

Rate of complications collected in the electronic medical using the Clavien-Dindo classification system for grading adverse events.

Classification of surgical complications:

Grade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.

Grade II - Requiring pharmacological treatment with drugs. Blood transfusions and total parenteral nutrition are also included

Grade III - Requiring surgical, endoscopic or radiological intervention Grade IIIa - Intervention not under general anesthesia Grade IIIb - Intervention under general anesthesia

Grade IV - Life threatening complication (including Central Nervous System (CNS) complications) requiring IC/ICU management Grade IVa - Single organ dysfunction (including dialysis) Grade IVb - Multiorgan dysfunction

Grade V - Death of a patient
2 months post surgery
In-hospital mortality
Time Frame: 10 days post-surgery
Has patient expired during in-hospital stay post-surgery.
10 days post-surgery
Date of Discharge
Time Frame: 10 days post-surgery
Measured in number of days
10 days post-surgery
Survival
Time Frame: 10 days, 2, months, annually through year 5
Assessed through follow-up visits. Data collected through patient's chart in the electronic medical record (EMR).
10 days, 2, months, annually through year 5
Disease reoccurrence
Time Frame: 10 day, 2 month and annually through year 5
Review of EMR records for new diagnosis assessed at schedule visits. Measured in number of days until reoccurrence diagnosis is noted in the patients' record.
10 day, 2 month and annually through year 5
30-Day Readmission
Time Frame: 30 days post surgery
Review of EMR records for any readmission following discharge post surgery
30 days post surgery
30-day complications
Time Frame: 30 days post surgery
Assessed as number of complications experienced by patient in the 30-day period post-surgery.
30 days post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AdventHealth

Investigators

  • Principal Investigator: Sharona Ross, MD, Adventhealth

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 14, 2024

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

July 29, 2024

First Submitted That Met QC Criteria

August 16, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

June 9, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1907766

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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