Hepatopancreaticobiliary and Foregut OperationsNCT06562179

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

A study testing da Vinci SP® Single-Port Robotic Surgical System in people with Hepatopancreaticobiliary and Foregut Operations, run by AdventHealth at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hepatopancreaticobiliary and Foregut Operations
What is being tested?: da Vinci SP® Single-Port Robotic Surgical System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 35 participants
Where: 1 siteUnited States
Study dates: 14 May 2024to Jun 2030
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Show all 54Show fewer

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)

Who cannot join

Cholecystectomy Stage 1- Exclusion Criteria:
Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Subjects with malignant disease

Show all 62Show fewer

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Daniel Robledo, MS contact

8139716000 ext. 56518

daniel.robledo@adventhealth.com

United States1 site, 1 recruiting

AdventhHealth
Tampa, Florida, 33613
Daniel Robledo, MS, 8139716000 ext. 56518, danel.robledo@adventhealth.com
Sharona Ross, MD
Recruiting

Other trials in United States

About this study

Official title: 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.

Conditions: Hepatopancreaticobiliary and Foregut Operations
Being tested: da Vinci SP® Single-Port Robotic Surgical System
Keywords: SP DaVinci, Gallbladder removal, Esophageal procedures, Gastric resections, Pancreas procedures, Liver procedures

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

da Vinci SP® Single-Port Robotic Surgical SystemDevice
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.

Study groups in NCT06562179
Study group	Role	What they receive
da Vinci SP® Single-Port Robotic Surgical System	Experimental	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 Receives: Device: da Vinci SP® Single-Port Robotic Surgical System

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (13)

Physical Status Classification
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
Measured: Pre-Operative Visit
Charlson Comorbidity Index Score
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)
Measured: Pre-Operative Visit
Operative Time
Measured in minutes
Measured: Intraoperative
Estimated blood loss
Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.
Measured: Intraoperatively
Intraoperative complications
Incidence rate - number of intraoperatively complications during surgery.
Measured: Intraoperatively
Postoperative complications
Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery.
Measured: 10 day, 2 months post surgery
Post surgery complications
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
Measured: 2 months post surgery
In-hospital mortality
Has patient expired during in-hospital stay post-surgery.
Measured: 10 days post-surgery
Date of Discharge
Measured in number of days
Measured: 10 days post-surgery
Survival
Assessed through follow-up visits. Data collected through patient's chart in the electronic medical record (EMR).
Measured: 10 days, 2, months, annually through year 5
Disease reoccurrence
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.
Measured: 10 day, 2 month and annually through year 5
30-Day Readmission
Review of EMR records for any readmission following discharge post surgery
Measured: 30 days post surgery
30-day complications
Assessed as number of complications experienced by patient in the 30-day period post-surgery.
Measured: 30 days post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

14 May 2024Jun 2030

First posted20 Aug 2024
Study start14 May 2024
Primary completionJun 2026 (estimated)
Study completionJun 2030 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (22)Papers the sponsor has linked to this study.
Other trials for Hepatopancreaticobiliary and Foregut OperationsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 35 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06562179
Sponsor's protocol ID: 1907766
Status last verified: Jun 2026
First submitted: 29 Jul 2024
Last updated: 11 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Rosemurgy A, Wilfong C, Craigg D, Co F, Sucandy I, Ross S. The Evolving Landscape of Esophageal Cancer: A Four-Decade Analysis. Am Surg. 2019 Sep 1;85(9):944-948.
PubMed 31638504
Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.
PubMed 23140831
Ross S, Rosemurgy A, Albrink M, Choung E, Dapri G, Gallagher S, Hernandez J, Horgan S, Kelley W, Kia M, Marks J, Martinez J, Mintz Y, Oleynikov D, Pryor A, Rattner D, Rivas H, Roberts K, Rubach E, Schwaitzberg S, Swanstrom L, Sweeney J, Wilson E, Zemon H, Zundel N. Consensus statement of the consortium for LESS cholecystectomy. Surg Endosc. 2012 Oct;26(10):2711-6. doi: 10.1007/s00464-012-2478-y. Epub 2012 Aug 31.
PubMed 22936433
Ross S, Roddenbery A, Luberice K, Paul H, Farrior T, Vice M, Patel K, Rosemurgy A. Laparoendoscopic single site (LESS) vs. conventional laparoscopic fundoplication for GERD: is there a difference? Surg Endosc. 2013 Feb;27(2):538-47. doi: 10.1007/s00464-012-2476-0. Epub 2012 Jul 18.
PubMed 22806533
Sukharamwala P, Teta A, Ross S, Co F, Alvarez-Calderon G, Luberice K, Rosemurgy A. Over 250 Laparoendoscopic Single Site (LESS) Fundoplications: Lessons Learned. Am Surg. 2015 Sep;81(9):870-5.
PubMed 26350663
Rosemurgy AS, Downs D, Swaid F, Ross SB. Laparoendoscopic Single-Site (LESS) Nissen Fundoplication: How We Do It. J Gastrointest Surg. 2016 Dec;20(12):2093-2099. doi: 10.1007/s11605-016-3290-0. Epub 2016 Oct 11. No abstract available.
PubMed 27730403
Ryan CE, Ross SB, Sukharamwala PB, Sadowitz BD, Wood TW, Rosemurgy AS. Distal pancreatectomy and splenectomy: a robotic or LESS approach. JSLS. 2015 Jan-Mar;19(1):e2014.00246. doi: 10.4293/JSLS.2014.00246.
PubMed 25848192
Barbaros U, Sumer A, Demirel T, Karakullukcu N, Batman B, Icscan Y, Saricam G, Serin K, Loh WL, Dinccag A, Mercan S. Single incision laparoscopic pancreas resection for pancreatic metastasis of renal cell carcinoma. JSLS. 2010 Oct-Dec;14(4):566-70. doi: 10.4293/108680810X12924466008448.
PubMed 21605524
Rosemurgy AS, Ross SB, Espeut A, Nguyen D, Crespo K, Syblis C, Vasanthakumar P, Sucandy I. Survival and Robotic Approach for Pancreaticoduodenectomy: A Propensity Score-Match Study. J Am Coll Surg. 2022 Apr 1;234(4):677-684. doi: 10.1097/XCS.0000000000000137.
PubMed 35290288
Rosemurgy A, Ross S, Bourdeau T, Craigg D, Spence J, Alvior J, Sucandy I. Robotic Pancreaticoduodenectomy Is the Future: Here and Now. J Am Coll Surg. 2019 Apr;228(4):613-624. doi: 10.1016/j.jamcollsurg.2018.12.040. Epub 2019 Jan 23.
PubMed 30682410
Rosemurgy A, Ross S, Bourdeau T, Jacob K, Thomas J, Przetocki V, Luberice K, Sucandy I. Cost Analysis of Pancreaticoduodenectomy at a High-Volume Robotic Hepatopancreaticobiliary Surgery Program. J Am Coll Surg. 2021 Apr;232(4):461-469. doi: 10.1016/j.jamcollsurg.2020.12.062. Epub 2021 Feb 10.
PubMed 33581292
Belfiori G, Crippa S, Francesca A, Pagnanelli M, Tamburrino D, Gasparini G, Partelli S, Andreasi V, Rubini C, Zamboni G, Falconi M. Long-Term Survivors after Upfront Resection for Pancreatic Ductal Adenocarcinoma: An Actual 5-Year Analysis of Disease-Specific and Post-Recurrence Survival. Ann Surg Oncol. 2021 Dec;28(13):8249-8260. doi: 10.1245/s10434-021-10401-7. Epub 2021 Jul 13.
PubMed 34258720
Sucandy I, Shapera E, Syblis CC, Crespo K, Przetocki VA, Ross SB, Rosemurgy AS. Propensity score matched comparison of robotic and open major hepatectomy for malignant liver tumors. Surg Endosc. 2022 Sep;36(9):6724-6732. doi: 10.1007/s00464-021-08948-3. Epub 2022 Jan 3.
PubMed 34981238
Aghayan DL, Kazaryan AM, Dagenborg VJ, Rosok BI, Fagerland MW, Waaler Bjornelv GM, Kristiansen R, Flatmark K, Fretland AA, Edwin B; OSLO-COMET Survival Study Collaborators. Long-Term Oncologic Outcomes After Laparoscopic Versus Open Resection for Colorectal Liver Metastases : A Randomized Trial. Ann Intern Med. 2021 Feb;174(2):175-182. doi: 10.7326/M20-4011. Epub 2020 Nov 17.
PubMed 33197213
Fretland AA, Dagenborg VJ, Bjornelv GMW, Kazaryan AM, Kristiansen R, Fagerland MW, Hausken J, Tonnessen TI, Abildgaard A, Barkhatov L, Yaqub S, Rosok BI, Bjornbeth BA, Andersen MH, Flatmark K, Aas E, Edwin B. Laparoscopic Versus Open Resection for Colorectal Liver Metastases: The OSLO-COMET Randomized Controlled Trial. Ann Surg. 2018 Feb;267(2):199-207. doi: 10.1097/SLA.0000000000002353.
PubMed 28657937

Study at a glance

From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
Acronym / sponsor ID: 1907766
Conditions: Hepatopancreaticobiliary and Foregut Operations
Keywords: SP DaVinci, Gallbladder removal, Esophageal procedures, Gastric resections, Pancreas procedures, Liver procedures
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 35 participants (estimated)
Lead sponsor: AdventHealthUniversity, hospital or other
Study start: 14 May 2024 (actual)
Primary completion: Jun 2026 (estimated)
Study completion: Jun 2030 (estimated)
First posted: 20 Aug 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
da Vinci SP® Single-Port Robotic Surgical System	Experimental	Device: da Vinci SP® Single-Port Robotic Surgical SystemThis 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

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (54 listed)

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

Key exclusion criteria (62 listed)

Subject requiring an emergent operation
Pregnancy or nursing
BMI > 26 kg/m2
Previous abdominal surgery
Subjects with malignant disease

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
da Vinci SP® Single-Port Robotic Surgical SystemThe 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.	Device	da Vinci SP® Single-Port Robotic Surgical System

Primary outcome

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.
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.
Number of Positive resection Margins
Time frame: 24 months
Number of positive resection margins in patients with Malignant disease.
Number of Lymph node yield
Time frame: 24 Months
Number of lymph node yield in patients with Malignant disease.

13 secondary outcomes

Physical Status Classification
Time frame: Pre-Operative Visit
Charlson Comorbidity Index Score
Time frame: Pre-Operative Visit
Operative Time
Time frame: Intraoperative
Estimated blood loss
Time frame: Intraoperatively
Intraoperative complications
Time frame: Intraoperatively
Postoperative complications
Time frame: 10 day, 2 months post surgery
Post surgery complications
Time frame: 2 months post surgery
In-hospital mortality
Time frame: 10 days post-surgery
Date of Discharge
Time frame: 10 days post-surgery
Survival
Time frame: 10 days, 2, months, annually through year 5
Disease reoccurrence
Time frame: 10 day, 2 month and annually through year 5
30-Day Readmission
Time frame: 30 days post surgery
30-day complications
Time frame: 30 days post surgery

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
Results publication: PubMed 31638504Rosemurgy A, Wilfong C, Craigg D, Co F, Sucandy I, Ross S. The Evolving Landscape of Esophageal Cancer: A Four-Decade Analysis. Am Surg. 2019 Sep 1;85(9):944-948.
Results publication: PubMed 23140831Golkar FC, Ross SB, Sperry S, Vice M, Luberice K, Donn N, Morton C, Hernandez JM, Rosemurgy AS. Patients' perceptions of laparoendoscopic single-site surgery: the cosmetic effect. Am J Surg. 2012 Nov;204(5):751-61. doi: 10.1016/j.amjsurg.2011.07.026.
Results publication: PubMed 22936433Ross S, Rosemurgy A, Albrink M, Choung E, Dapri G, Gallagher S, Hernandez J, Horgan S, Kelley W, Kia M, Marks J, Martinez J, Mintz Y, Oleynikov D, Pryor A, Rattner D, Rivas H, Roberts K, Rubach E, Schwaitzberg S, Swanstrom L, Sweeney J, Wilson E, Zemon H, Zundel N. Consensus statement of the consortium for LESS cholecystectomy. Surg Endosc. 2012 Oct;26(10):2711-6. doi: 10.1007/s00464-012-2478-y. Epub 2012 Aug 31.
Results publication: PubMed 22806533Ross S, Roddenbery A, Luberice K, Paul H, Farrior T, Vice M, Patel K, Rosemurgy A. Laparoendoscopic single site (LESS) vs. conventional laparoscopic fundoplication for GERD: is there a difference? Surg Endosc. 2013 Feb;27(2):538-47. doi: 10.1007/s00464-012-2476-0. Epub 2012 Jul 18.
Results publication: PubMed 26350663Sukharamwala P, Teta A, Ross S, Co F, Alvarez-Calderon G, Luberice K, Rosemurgy A. Over 250 Laparoendoscopic Single Site (LESS) Fundoplications: Lessons Learned. Am Surg. 2015 Sep;81(9):870-5.
Results publication: PubMed 27730403Rosemurgy AS, Downs D, Swaid F, Ross SB. Laparoendoscopic Single-Site (LESS) Nissen Fundoplication: How We Do It. J Gastrointest Surg. 2016 Dec;20(12):2093-2099. doi: 10.1007/s11605-016-3290-0. Epub 2016 Oct 11. No abstract available.
Results publication: PubMed 25848192Ryan CE, Ross SB, Sukharamwala PB, Sadowitz BD, Wood TW, Rosemurgy AS. Distal pancreatectomy and splenectomy: a robotic or LESS approach. JSLS. 2015 Jan-Mar;19(1):e2014.00246. doi: 10.4293/JSLS.2014.00246.
Results publication: PubMed 21605524Barbaros U, Sumer A, Demirel T, Karakullukcu N, Batman B, Icscan Y, Saricam G, Serin K, Loh WL, Dinccag A, Mercan S. Single incision laparoscopic pancreas resection for pancreatic metastasis of renal cell carcinoma. JSLS. 2010 Oct-Dec;14(4):566-70. doi: 10.4293/108680810X12924466008448.
Results publication: PubMed 35290288Rosemurgy AS, Ross SB, Espeut A, Nguyen D, Crespo K, Syblis C, Vasanthakumar P, Sucandy I. Survival and Robotic Approach for Pancreaticoduodenectomy: A Propensity Score-Match Study. J Am Coll Surg. 2022 Apr 1;234(4):677-684. doi: 10.1097/XCS.0000000000000137.
Results publication: PubMed 30682410Rosemurgy A, Ross S, Bourdeau T, Craigg D, Spence J, Alvior J, Sucandy I. Robotic Pancreaticoduodenectomy Is the Future: Here and Now. J Am Coll Surg. 2019 Apr;228(4):613-624. doi: 10.1016/j.jamcollsurg.2018.12.040. Epub 2019 Jan 23.
Results publication: PubMed 33581292Rosemurgy A, Ross S, Bourdeau T, Jacob K, Thomas J, Przetocki V, Luberice K, Sucandy I. Cost Analysis of Pancreaticoduodenectomy at a High-Volume Robotic Hepatopancreaticobiliary Surgery Program. J Am Coll Surg. 2021 Apr;232(4):461-469. doi: 10.1016/j.jamcollsurg.2020.12.062. Epub 2021 Feb 10.
Results publication: PubMed 34258720Belfiori G, Crippa S, Francesca A, Pagnanelli M, Tamburrino D, Gasparini G, Partelli S, Andreasi V, Rubini C, Zamboni G, Falconi M. Long-Term Survivors after Upfront Resection for Pancreatic Ductal Adenocarcinoma: An Actual 5-Year Analysis of Disease-Specific and Post-Recurrence Survival. Ann Surg Oncol. 2021 Dec;28(13):8249-8260. doi: 10.1245/s10434-021-10401-7. Epub 2021 Jul 13.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Daniel Robledo, MS contact

8139716000 ext. 56518

daniel.robledo@adventhealth.com

Sharona Ross, MD principal investigator

AdventHealth

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing da Vinci SP® Single-Port Robotic Surgical System in people with Hepatopancreaticobiliary and Foregut Operations, run by AdventHealth at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 54 inclusion and 62 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Daniel Robledo, MS (8139716000 ext. 56518, daniel.robledo@adventhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Completion Using the planned da Vinci SP-assisted Single Port Robot. (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06562179, which also lists 22 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.