[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644022":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":50,"centralContacts":54,"locations":62,"responsibleParty":80,"collaborators":36,"id":83,"slug":84,"hasResults":85,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":36,"eligibilityCriteria":89,"healthyVolunteers":85,"sex":90,"minAge":91,"maxAge":36,"enrollmentInfo":92,"targetDuration":36,"studyType":95,"phases":96,"briefSummary":98,"conditions":99,"keywords":36,"overallStatus":65,"whyStopped":36,"lastUpdateSubmitDate":101,"lastUpdatePostDateStruct":102,"startDateStruct":105,"completionDateStruct":107,"leadSponsor":109,"locationsCount":110},{"fullName":5,"class":6},"Icahn School of Medicine at Mount Sinai","OTHER",[8,14,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Balloon Tamponade with no hemostatic agent","ACTIVE_COMPARATOR","Balloon tamponade alone with no hemostatic agent acts as a control.",[13],"Procedure: Balloon Tamponade",{"label":15,"type":16,"description":17,"interventionNames":18},"Balloon Tamponade with Floseal","EXPERIMENTAL","Balloon tamponade with Floseal as hemostatic agent.",[19,13],"Device: Floseal",{"label":21,"type":16,"description":22,"interventionNames":23},"Balloon Tamponade with Surgicel","Balloon Tamponade with Surgicel as hemostatic agent.",[24,13],"Device: Surgicel",{"label":26,"type":16,"description":27,"interventionNames":28},"Balloon Tamponade with Surgiflo","Balloon tamponade with Surgilfo as hemostatic agent.",[29,13],"Device: Surgiflo",[31,37,41,45],{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"DEVICE","Floseal","Floseal is an active, flowable hemostatic matrix designed to stop surgical bleeding fast, usually within 2 minutes, by combining gelatin granules with human thrombin.",[15],null,{"type":32,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Surgicel","SURGICEL® (oxidized regenerated cellulose) is a plant-based, absorbable hemostatic fabric used to control capillary, venous, and small arterial bleeding.",[21],{"type":32,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Surgiflo","SURGIFLO® Hemostatic Matrix is an Ethicon porcine gelatin-based, flowable hemostatic agent used to stop bleeding during surgery, typically reaching hemostasis within seconds to minutes.",[26],{"type":46,"name":47,"description":48,"armGroupLabels":49,"otherNames":36},"PROCEDURE","Balloon Tamponade","Balloon tamponade is utilized to manage tract related bleeding.",[15,21,26,9],[51],{"name":52,"affiliation":5,"role":53},"Mantu Gupta, MD","PRINCIPAL_INVESTIGATOR",[55,59],{"name":52,"role":56,"phone":57,"phoneExt":36,"email":58},"CONTACT","212-241-1272","mantu.gupta@mountsinai.org",{"name":60,"role":56,"phone":57,"phoneExt":36,"email":61},"Blair Gallante, MPH","blair.gallante@mountsinai.org",[63],{"facility":64,"status":65,"city":66,"state":66,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Mount Sinai West","RECRUITING","New York","10019","United States","US",{"type":71,"coordinates":72},"Point",[73,74],-74.00597,40.71427,{"lat":74,"lon":73},[77,78,79],{"name":52,"role":56,"phone":57,"phoneExt":36,"email":58},{"name":60,"role":56,"phone":57,"phoneExt":36,"email":61},{"name":52,"role":53,"phone":36,"phoneExt":36,"email":36},{"type":53,"investigatorFullName":81,"investigatorTitle":82,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Mantu Gupta","Professor of Urology","100644022","tract-closure-in-pcnl-100644022",false,"NCT07668817","Tract Closure in PCNL","Defining the Role of Hemostatic Agents in Percutaneous Nephrolithotomy: A Randomized Controlled Trial of Tract Closure Techniques","Inclusion criteria:\n\n* At least one stone ≥ 1.2cm\n* Scheduled to undergo planned PCNL\n* Age ≥ 18 years\n\nExclusion criteria:\n\n* Unable to provide informed consent\n* Pre-existing nephrostomy tube\n* Multi access cases\n* Stone in calyceal diverticulum\u002Fhydrocalyx\n* Preoperatively planned overnight admission for any reason\n* Infundibular stenosis\n* Coagulation disorders\n* Other significant anatomic abnormalities","ALL","18 Years",{"count":93,"type":94},92,"ESTIMATED","INTERVENTIONAL",[97],"NA","This is a prospective, randomized controlled trial evaluating the effect of a hemostatic agent on tract-related bleeding during percutaneous nephrolithotomy (PCNL). Patients undergoing standardized PCNL will be randomized to receive either application of a hemostatic agent or no agent during tract closure, following uniform balloon occlusion, complete aspiration, and irrigation-free endoscopic assessment. The researchers hypothesize that adjunctive hemostatic agent use reduces perioperative hemoglobin decline compared with balloon tamponade alone and improves tract-related hemostasis outcomes.",[100],"Nephrolithiasis","2026-06-21",{"date":103,"type":104},"2026-06-25","ACTUAL",{"date":106,"type":94},"2026-07",{"date":108,"type":94},"2028-06",{"name":5,"class":6},1]