Single-Port robot takes on complex belly surgeries
NCT ID NCT06562179
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study is testing a new robotic system that uses just one small incision to perform surgeries on the liver, pancreas, stomach, and esophagus. The goal is to see if this single-port approach is safe and works well for these complex operations. The study will enroll 35 adults with either benign or malignant conditions who need these surgeries.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- da Vinci SP® Single-Port Robotic Surgical System (device)
- What this could lead to
- If successful, this could show that single-port robotic surgery is a safe and effective option for complex abdominal surgeries, potentially leading to less pain and faster recovery.
- What could go wrong
- This is a small, early-stage study with only 35 participants, so results may not apply to everyone. The surgery is complex and carries risks like infection, bleeding, or need to switch to a different surgical approach.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 35 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2024
- Expected to finish
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Jun 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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AdventhHealth
RECRUITINGTampa, Florida, 33613, United States
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