A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease
NCT ID: NCT06562179
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
35 participants
INTERVENTIONAL
2024-05-14
2030-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Using da Vinci SP System for Patients With Cholelithiasis and Choledocholithiasis
NCT06852937
Observation of Perioperative Outcomes of Robotic Pancreaticoduodenectomy
NCT04171440
Pancreaticoduodenectomy With or Without Preoperative Hyperbaric Oxygen Therapy
NCT02575014
A Prospective Clinical Study Using an Artery-first Intermediate Approach in Robot-assisted Pancreaticoduodenectomy
NCT05660915
A Prospective Study on the Safety and Efficacy of Robot-assisted Pancreaticoduodenectomy
NCT05755594
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AdventHealth
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sharona B. Ross, MD
MD, Foregut and HPB Surgeon
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sharona Ross, MD
Role: PRINCIPAL_INVESTIGATOR
AdventHealth
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AdventhHealth
Tampa, Florida, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Shapera E, Sucandy I, Syblis C, Crespo K, Ja'Karri T, Ross S, Rosemurgy A. Cost analysis of robotic versus open hepatectomy: Is the robotic platform more expensive? J Robot Surg. 2022 Dec;16(6):1409-1417. doi: 10.1007/s11701-022-01375-z. Epub 2022 Feb 13.
Wecowski J, Ross SB, Jadick MF, Justice A, Sucandy I, Rosemurgy AS. THE Big Deal: An Institution's Experience with Robotic Transhiatal Esophagectomy. Am Surg. 2019 Sep 1;85(9):1061-1065.
van den Berg JW, Luketich JD, Cheong E. Oesophagectomy: The expanding role of minimally invasive surgery in oesophageal cancer. Best Pract Res Clin Gastroenterol. 2018 Oct-Dec;36-37:75-80. doi: 10.1016/j.bpg.2018.11.001. Epub 2018 Nov 21.
Giulianotti PC, Coratti A, Angelini M, Sbrana F, Cecconi S, Balestracci T, Caravaglios G. Robotics in general surgery: personal experience in a large community hospital. Arch Surg. 2003 Jul;138(7):777-84. doi: 10.1001/archsurg.138.7.777.
Sucandy I, Jacoby H, Crespo K, Syblis C, App S, Ignatius J, Ross S, Rosemurgy A. A Single Institution's Experience With Robotic Minor and Major Hepatectomy. Am Surg. 2023 May;89(5):1387-1391. doi: 10.1177/00031348211047500. Epub 2021 Nov 19.
Rosemurgy AS, Luberice K, Krill E, Castro M, Espineira GR, Sucandy I, Ross S. 100 Robotic Distal Pancreatectomies: The Future at Hand. Am Surg. 2020 Aug;86(8):958-964. doi: 10.1177/0003134820942181. Epub 2020 Aug 11.
Qu L, Zhiming Z, Xianglong T, Yuanxing G, Yong X, Rong L, Yee LW. Short- and mid-term outcomes of robotic versus laparoscopic distal pancreatosplenectomy for pancreatic ductal adenocarcinoma: A retrospective propensity score-matched study. Int J Surg. 2018 Jul;55:81-86. doi: 10.1016/j.ijsu.2018.05.024. Epub 2018 May 23.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
1907766
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.