Using the da Vinci SP Surgical System for liver and stomach surgeries
Official title: A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.
Run by AdventHealth · NCT06562179 · Data updated 2026-11-12
This study is testing if the da Vinci SP Surgical System can safely and effectively perform liver and stomach surgeries for adults aged 18 to 80.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | AdventHealth Academic / other |
| Locations | 1 site (Tampa, Florida) |
| Status | Recruiting |
| Started | May 14, 2024 |
| Main results expected | June 2026 |
| Study ends | June 2030 |
| Registry record updated | June 11, 2026 |
| Trial ID | NCT06562179 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 to 80 with specific benign or early malignant conditions affecting the liver, pancreas, or stomach.
✕Probably not a fit
Patients with a BMI over 26 or those with advanced metastatic disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and performance of the da Vinci SP Surgical System in performing hepatopancreaticobiliary and foregut operations, including procedures like gallbladder removal and esophageal surgeries. It aims to collect data on the effectiveness of this robotic surgical system for both benign and malignant conditions. The study will involve patients aged 18 to 80 with specific health criteria, ensuring a controlled environment for assessing outcomes.
Why it matters
Potential benefit: If successful, this study could enhance surgical precision and recovery times for patients undergoing complex abdominal surgeries.
How similar studies have gone: Other studies using robotic surgical systems have shown promising results, indicating potential for success with this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
AdventhHealth
Tampa, Florida, United States Recruiting
Study contacts
- Principal investigator: Sharona Ross, MD — AdventHealth
- Study coordinator: Daniel Robledo, MS
- Email: daniel.robledo@adventhealth.com
- Phone: 8139716000
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.