[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646686":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":10,"centralContacts":20,"locations":10,"responsibleParty":26,"collaborators":30,"id":33,"slug":34,"hasResults":35,"nctId":36,"briefTitle":37,"officialTitle":38,"acronym":10,"eligibilityCriteria":39,"healthyVolunteers":35,"sex":40,"minAge":41,"maxAge":10,"enrollmentInfo":42,"targetDuration":45,"studyType":46,"phases":10,"briefSummary":47,"conditions":48,"keywords":50,"overallStatus":54,"whyStopped":10,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":59,"completionDateStruct":61,"leadSponsor":63,"locationsCount":10},{"fullName":5,"class":6},"Hospital del Mar","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Robotic Distal Pancreatectomy with Radiofrequency",null,"Participants undergoing robotic distal pancreatectomy in which pancreatic parenchymal transection is performed using the Attachable Coolingbis® radiofrequency device.",[13],"Device: Internally-cooled bipolar radiofrequency device",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":10},"DEVICE","Internally-cooled bipolar radiofrequency device","A robotic-compatible, internally-cooled bipolar radiofrequency device (Attachable Coolingbis®, ACB) used to coagulate and transect the pancreatic parenchyma during robotic distal pancreatectomy.",[9],[21],{"name":22,"role":23,"phone":24,"phoneExt":10,"email":25},"Benedetto Ielpo, MD, PhD","CONTACT","0034 932 48 30 00","ielpo.b@gmail.com",{"type":27,"investigatorFullName":28,"investigatorTitle":29,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Benedetto Ielpo","Head of Surgical Unit, Associate Professor of Pompeu Fabra University , Principal Investigator",[31],{"name":32,"class":6},"Hospital del Mar Research Institute (IMIM)","100646686","attachable-coolingbis-for-distal-pancreatectomy-100646686",false,"NCT07687901","Attachable Coolingbis® for Distal Pancreatectomy","Safety and Feasibility of Radiofrequency-Assisted Robotic Distal Pancreatectomy (Attachable Coolingbis®)","Inclusion Criteria:\n\n* Age 18 years or older\n* Diagnosis of solid or cystic pancreatic neoplasm (benign, premalignant, or malignant) with surgical indication\n* Requirement for distal pancreatectomy with a planned transection line located more than 2 cm to the left of the medial border of the superior mesenteric vein (SMV), confirmed by CT or MRI performed within 2 months prior to surgery\n* Eligible for either splenic-preserving distal pancreatectomy or distal splenopancreatectomy\n* Eligible for open or minimally invasive surgical approach (laparoscopic or robotic)\n* Able to provide written informed consent\n\nExclusion Criteria:\n\n* ASA (American Society of Anesthesiologists) physical status classification greater than 3\n* Legal or cognitive incapacity to sign informed consent\n* Confirmed or ongoing pregnancy\n* Need for emergency surgery (e.g., post-traumatic pathology or acute complications)","ALL","18 Years",{"count":43,"type":44},20,"ESTIMATED","90 Days","OBSERVATIONAL","This pilot study evaluates the safety and technical feasibility of a new radiofrequency-assisted device, the Attachable Coolingbis® (ACB), when used during robotic distal pancreatectomy. Distal pancreatectomy, a common operation for tumors of the body or tail of the pancreas, carries a high risk of postoperative pancreatic fistula (occurring in 30-40% of cases) because standard stapling techniques often fail to achieve an effective biological seal of the pancreatic remnant. The ACB device applies radiofrequency energy to coagulate and seal the pancreatic tissue before transection, a technique that has shown promising results in laparoscopic surgery and in preclinical robotic testing. This study adapts the device for use on the robotic surgical platform for the first time in humans.\n\nTwenty adult patients undergoing robotic distal pancreatectomy for benign, premalignant, or malignant pancreatic tumors will be enrolled across four Spanish hospitals. All participants will receive the robotic procedure with the ACB device; there is no comparison group, as this is an exploratory, single-arm study. The main goal is to determine whether the device can be used safely and effectively, by monitoring serious adverse events, pancreatic fistula, bleeding, and other surgical complications occurring up to 90 days after surgery. Participants will also be followed for one year to assess longer-term outcomes, including pancreatic function, tumor recurrence, and quality of life.",[49],"Pancreatectomy",[51,52,53],"Robot","Distal Pancreatectomy","Radiofrequency","NOT_YET_RECRUITING","2026-06-30",{"date":57,"type":58},"2026-07-07","ACTUAL",{"date":60,"type":44},"2026-09-01",{"date":62,"type":44},"2027-08-01",{"name":5,"class":6}]