[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611006":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":43,"centralContacts":47,"locations":52,"responsibleParty":78,"collaborators":35,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":35,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":35,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":104,"overallStatus":55,"whyStopped":35,"lastUpdateSubmitDate":120,"lastUpdatePostDateStruct":121,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":129},{"fullName":5,"class":6},"Thomas Jefferson University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Arm 1: Ureteral Stent","EXPERIMENTAL","Subjects randomized to the stent arm will receive ureteral stents (double J or single J ureteral catheter, per surgeon preference) during radical cystectomy with ileal conduit urinary diversion (RCIC). Intraoperative use of indocyanine green with fluorescence imaging with be noted. Ureteral stents will be placed intraoperatively and removed at follow up visit per surgeon discretion. Either approach would be considered standard of care for muscle invasive bladder cancer, for which radical cystectomy with urinary diversion is the gold standard of treatment. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.",[13,14],"Procedure: Ureteral Stent Placement","Diagnostic Test: Indocyanine Green with Fluorescence Imaging",{"label":16,"type":17,"description":18,"interventionNames":19},"Arm 2: No Ureteral Stent","ACTIVE_COMPARATOR","Subjects randomized to the no-stent arm will undergo radical cystectomy with ileal conduit urinary diversion (RCIC) without placement of ureteral stents. They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.",[20,14],"Procedure: No Ureteral Stent",[22,31,36],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"PROCEDURE","Ureteral Stent Placement","Placement of ureteral stents (double J or single J) intraoperatively during radical cystectomy with ileal conduit urinary diversion (RCIC). Stent placement will be a one-time occurrence inserted during RCIC, and be removed typically between 7-21 days post-op at the discretion of the surgeon.",[9],[28,29,30],"double J","single J","ureteral stents",{"type":23,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"No Ureteral Stent","Radical cystectomy with ileal conduit urinary diversion (RCIC) performed without ureteral stent placement.",[16],null,{"type":37,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"DIAGNOSTIC_TEST","Indocyanine Green with Fluorescence Imaging","Indocyanine green (ICG) with fluorescence imaging is an advanced technique used to enhance the visualization of the ureters during complex pelvic surgeries, such as those for bladder cancer. The technology helps surgeons identify the ureters, which are the tubes connecting the kidneys to the bladder, and distinguish them from surrounding tissues.",[9,16],[42],"ICG",[44],{"name":45,"affiliation":5,"role":46},"Mihir S Shah, MD","PRINCIPAL_INVESTIGATOR",[48],{"name":45,"role":49,"phone":50,"phoneExt":35,"email":51},"CONTACT","215-955-6961","Mihir.Shah@jefferson.edu",[53,69],{"facility":54,"status":55,"city":56,"state":57,"zip":58,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":66,"contacts":67},"Thomas Jefferson University Hospital","RECRUITING","Philadelphia","Pennsylvania","19107","United States","US",{"type":62,"coordinates":63},"Point",[64,65],-75.16362,39.95238,{"lat":65,"lon":64},[68],{"name":45,"role":49,"phone":50,"phoneExt":35,"email":35},{"facility":70,"status":71,"city":56,"state":57,"zip":72,"country":59,"countryCode":60,"cosmosGeoPoint":73,"geoPoint":75,"contacts":76},"Jefferson Einstein Philadelphia Hospital","NOT_YET_RECRUITING","19141",{"type":62,"coordinates":74},[64,65],{"lat":65,"lon":64},[77],{"name":45,"role":49,"phone":50,"phoneExt":35,"email":35},{"type":79,"investigatorFullName":35,"investigatorTitle":35,"investigatorAffiliation":35,"oldNameTitle":35,"oldOrganization":35},"SPONSOR","100611006","clinical-trial-to-evaluate-post-operative-outcomes-of-ureteral-stent-vs-ureteral-stent-free-radical-cystectomy-100611006",false,"NCT07234968","Clinical Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","Randomized Controlled Trial to Evaluate Post-Operative Outcomes of Ureteral Stent vs Ureteral Stent Free Radical Cystectomy","Inclusion Criteria:\n\n* Individuals must meet all the following inclusion criteria to be eligible to participate in the study:\n\n  * Provide signed and dated informed consent form\n  * Willing to comply with all study procedures and be available for the duration of the study\n  * Male or female, age 18 to 85\n  * Diagnosed with bladder cancer, other pelvic malignancies necessitating a cystectomy (e.g.: colorectal, prostate, gynecologic) and have elected for a cystectomy with ileal conduit urinary diversion\n\nExclusion Criteria:\n\n* An individual who meets any of the following criteria will be excluded from participation in this study:\n\n  * Current or history of pelvic radiation\n  * Retroperitoneal fibrosis\n  * Untreated urinary tract infection (UTI) within 30 days prior to RCIC\n  * Pregnancy","ALL","18 Years","85 Years",{"count":91,"type":92},70,"ESTIMATED","INTERVENTIONAL",[95],"NA","Subjects will be randomized into 2 groups (stent or no stent) prior to radical cystectomy with ileal conduit urinary diversion (RCIC). They will follow the standard of care and be enrolled in the study for 12 months post-op. Risk of post-op complications will be analyzed.",[98,99,100,101,102,103],"Bladder Cancer","Muscle-Invasive Bladder Carcinoma","Urothelial Carcinoma","Pelvic Malignancy","Bladder Transitional Cell Carcinoma","Bladder Neoplasm",[105,106,107,108,109,101,98,110,111,112,113,30,114,115,116,117,118,119],"Bladder","Stent-free Cystectomy","Urinary Tract Infection","Urinary Leak","UTI","Urologic Oncology","Muscle-invasive Bladder Cancer","indocyanine green","fluorescence imaging","RCIC","cystectomy","colorectal","prostate","gynecologic","ileal conduit urinary diversion","2026-02-12",{"date":122,"type":123},"2026-02-17","ACTUAL",{"date":125,"type":123},"2025-12-23",{"date":127,"type":92},"2028-04-30",{"name":5,"class":6},2]