[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100559288":3},{"organization":4,"outcomesModule":7,"designInfo":74,"detailedDescription":73,"studyPopulation":73,"armGroups":80,"interventions":87,"overallOfficials":92,"centralContacts":96,"locations":103,"responsibleParty":125,"collaborators":73,"id":128,"slug":73,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":73,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":73,"studyType":140,"phases":141,"briefSummary":142,"conditions":143,"keywords":145,"overallStatus":106,"whyStopped":73,"lastUpdateSubmitDate":152,"lastUpdatePostDateStruct":153,"startDateStruct":156,"completionDateStruct":158,"leadSponsor":160,"locationsCount":161},{"fullName":5,"class":6},"AdventHealth","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":24,"otherOutcomes":73},[9,13,17,20],{"measure":10,"description":11,"timeFrame":12},"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.","12 months",{"measure":14,"description":15,"timeFrame":16},"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.","24 months",{"measure":18,"description":19,"timeFrame":16},"Number of Positive resection Margins","Number of positive resection margins in patients with Malignant disease.",{"measure":21,"description":22,"timeFrame":23},"Number of Lymph node yield","Number of lymph node yield in patients with Malignant disease.","24 Months",[25,29,32,36,40,43,47,51,55,58,62,66,70],{"measure":26,"description":27,"timeFrame":28},"Physical Status Classification","Assessment of the fitness of patient before surgery using the ASA Physical Status Score:\n\nClass 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",{"measure":30,"description":31,"timeFrame":28},"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.\n\nThis 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)",{"measure":33,"description":34,"timeFrame":35},"Operative Time","Measured in minutes","Intraoperative",{"measure":37,"description":38,"timeFrame":39},"Estimated blood loss","Measured after surgery in milliliters of blood. Estimated based on blood infusion volume during the surgery.","Intraoperatively",{"measure":41,"description":42,"timeFrame":39},"Intraoperative complications","Incidence rate - number of intraoperatively complications during surgery.",{"measure":44,"description":45,"timeFrame":46},"Postoperative complications","Incidence number of complications, assessed through electronic medical records (EMR) at 10 days 60 days post-surgery.","10 day, 2 months post surgery",{"measure":48,"description":49,"timeFrame":50},"Post surgery complications","Rate of complications collected in the electronic medical using the Clavien-Dindo classification system for grading adverse events.\n\nClassification of surgical complications:\n\nGrade I - Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic and radiological interventions.\n\nGrade II - Requiring pharmacological treatment with drugs. Blood transfusions and total parenteral nutrition are also included\n\nGrade III - Requiring surgical, endoscopic or radiological intervention Grade IIIa - Intervention not under general anesthesia Grade IIIb - Intervention under general anesthesia\n\nGrade IV - Life threatening complication (including Central Nervous System (CNS) complications) requiring IC\u002FICU management Grade IVa - Single organ dysfunction (including dialysis) Grade IVb - Multiorgan dysfunction\n\nGrade V - Death of a patient","2 months post surgery",{"measure":52,"description":53,"timeFrame":54},"In-hospital mortality","Has patient expired during in-hospital stay post-surgery.","10 days post-surgery",{"measure":56,"description":57,"timeFrame":54},"Date of Discharge","Measured in number of days",{"measure":59,"description":60,"timeFrame":61},"Survival","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",{"measure":63,"description":64,"timeFrame":65},"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.","10 day, 2 month and annually through year 5",{"measure":67,"description":68,"timeFrame":69},"30-Day Readmission","Review of EMR records for any readmission following discharge post surgery","30 days post surgery",{"measure":71,"description":72,"timeFrame":69},"30-day complications","Assessed as number of complications experienced by patient in the 30-day period post-surgery.",null,{"allocation":75,"interventionModel":76,"interventionModelDescription":73,"primaryPurpose":77,"observationalModel":73,"timePerspective":73,"maskingInfo":78},"NA","SINGLE_GROUP","TREATMENT",{"masking":79,"maskingDescription":73,"whoMasked":73},"NONE",[81],{"label":82,"type":83,"description":84,"interventionNames":85},"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.\n\nStage 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.\n\nStage Two will include five (5) subjects who undergo gastrectomy and five (5) subjects who undergo distal pancreatectomy for a total of ten (10) subjects.\n\nStage Three will include five (5) subjects who undergo pancreaticoduodenectomy and five (5) subjects who undergo esophagectomy for a total of ten (10) subjects.\n\nStage Four will include five (5) subjects who undergo hepatectomy",[86],"Device: da Vinci SP® Single-Port Robotic Surgical System",[88],{"type":89,"name":82,"description":90,"armGroupLabels":91,"otherNames":73},"DEVICE","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.",[82],[93],{"name":94,"affiliation":5,"role":95},"Sharona Ross, MD","PRINCIPAL_INVESTIGATOR",[97],{"name":98,"role":99,"phone":100,"phoneExt":101,"email":102},"Daniel Robledo, MS","CONTACT","8139716000","56518","daniel.robledo@adventhealth.com",[104],{"facility":105,"status":106,"city":107,"state":108,"zip":109,"country":110,"countryCode":111,"cosmosGeoPoint":112,"geoPoint":117,"contacts":118},"AdventhHealth","RECRUITING","Tampa","Florida","33613","United States","US",{"type":113,"coordinates":114},"Point",[115,116],-82.45843,27.94752,{"lat":116,"lon":115},[119,121,122],{"name":98,"role":99,"phone":100,"phoneExt":101,"email":120},"danel.robledo@adventhealth.com",{"name":94,"role":95,"phone":73,"phoneExt":73,"email":73},{"name":123,"role":124,"phone":73,"phoneExt":73,"email":73},"Iswanto Sucandy, MD","SUB_INVESTIGATOR",{"type":95,"investigatorFullName":126,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":73,"oldOrganization":73},"Sharona B. Ross, MD","MD, Foregut and HPB Surgeon","100559288",false,"NCT06562179","A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease","A Prospective, Single-Center Investigation of the da Vinci SP® Surgical System in Hepatopancreaticobiliary and Foregut Operations for Benign and Malignant Disease.","Inclusion Criteria\n\nCholecystectomy Stage 1 - Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either male or female\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign disease\n\nFundoplication Stage 1- Inclusion Criteria:\n\n* Patients diagnosed with GERD and\u002For hiatal hernia\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n\nGastrectomy Stage 2- Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign or relatively early malignant disease of the stomach\n* AJCC 8th edition T0 or T1 tumor pathology\n* AJCC 8th edition T2, T3, tumor pathology (following neoadjuvant therapy if necessary) at the discretion of the investigator\n* Free of metastatic disease\n\nDistal Pancreatectomy Stage 2- Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign or malignant disease of the pancreas\n* No vascular involvement\n* Free of metastatic disease\n\nPancreaticoduodenectomy Stage 3- Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign or malignant disease of the pancreas\n* Diagnosed with benign or malignant distal bile duct disease\n* No vasculature involvement (i.e., no T4 disease, pancreatic or Stage 4a or b disease, or distal bile duct Stage 3b or 4 disease)\n* Free of metastatic disease\n\nEsophagectomy Stage 3- Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign or malignant disease of the esophagus\n* AJCC 8th edition T0, T1a, T1b, T2 (without other indications for neoadjuvant therapy) tumor pathology\n* AJCC 8th edition some T2, T3, or T4a, (following neoadjuvant therapy) at the discretion of the investigator\n* Free of metastatic disease\n\nHepatectomy Stage 4- Inclusion Criteria:\n\n* Patients between the ages of 18 and 80 years of age\n* Either men or women\n* BMI ≤ 26 kg\u002Fm2\n* ASA ≤ 3\n* Diagnosed with benign or malignant disease of the liver or bile duct\n* Free of metastatic disease, not including metastatic disease to the liver (e.g., colorectal liver metastases)\n\nExclusion Criteria\n\nCholecystectomy Stage 1- Exclusion Criteria:\n\n* Subject requiring an emergent operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Subjects with malignant disease\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n\nFundoplication Stage 1- Exclusion Criteria:\n\n* Subject requiring an emergent operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n\nGastrectomy Stage 2- Exclusion Criteria:\n\n* Subject requiring an emergency operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n* AJCC 8th edition T2, T3, T4a, T4b tumor pathology (without neoadjuvant therapy unless contraindicated)\n* Clinical or radiological evidence of distant metastatic disease\n\nDistal Pancreatectomy Stage 2- Exclusion Criteria:\n\n* Subject requiring an emergent operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n* Tumor involvement with surrounding vasculature (e.g., common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)\n* Clinical or radiological evidence of metastatic disease\n\nPancreaticoduodenectomy Stage 3- Exclusion Criteria:\n\n* Subject requiring an emergent operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n* Tumor involvement with surrounding vasculature (e.g., T4a for pancreatic disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)\n* Tumor involvement with surrounding vasculature (e.g., T3b for bile duct disease: common hepatic artery, superior mesenteric artery, superior mesenteric vein, portal vein)\n* Clinical or radiological evidence of metastatic disease\n\nEsophagectomy Stage 3- Exclusion Criteria:\n\n* Subject requiring an emergency operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n* AJCC 8th edition T2 (in some circumstances), T3, and T4a tumor pathology (without neoadjuvant therapy)\n* Clinical or radiological evidence of distant metastatic disease\n\nHepatectomy Stage 4- Exclusion Criteria:\n\n* Subject requiring an emergency operation\n* Pregnancy or nursing\n* BMI \\> 26 kg\u002Fm2\n* Previous abdominal surgery\n* Inability to provide informed consent\n* Contraindicated for general anesthesia or minimally invasive surgery\n* Perihilar cholangiocarcinoma (i.e., Klatskin tumor)\n* Involvement of major vasculature (ex: portal vein, hepatic artery, or inferior vena cava)\n* Clinical or radiological evidence of metastatic disease","ALL","18 Years","80 Years",{"count":138,"type":139},35,"ESTIMATED","INTERVENTIONAL",[75],"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.",[144],"Hepatopancreaticobiliary and Foregut Operations",[146,147,148,149,150,151],"SP DaVinci","Gallbladder removal","Esophageal procedures","Gastric resections","Pancreas procedures","Liver procedures","2026-06-09",{"date":154,"type":155},"2026-06-11","ACTUAL",{"date":157,"type":155},"2024-05-14",{"date":159,"type":139},"2030-06",{"name":5,"class":6},1]