[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100505799":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":39,"centralContacts":43,"locations":53,"responsibleParty":274,"collaborators":277,"id":282,"slug":283,"hasResults":284,"nctId":285,"briefTitle":286,"officialTitle":287,"acronym":30,"eligibilityCriteria":288,"healthyVolunteers":284,"sex":289,"minAge":290,"maxAge":30,"enrollmentInfo":291,"targetDuration":30,"studyType":294,"phases":295,"briefSummary":297,"conditions":298,"keywords":301,"overallStatus":56,"whyStopped":30,"lastUpdateSubmitDate":306,"lastUpdatePostDateStruct":307,"startDateStruct":310,"completionDateStruct":312,"leadSponsor":314,"locationsCount":315},{"fullName":5,"class":6},"University of Michigan","OTHER",[8,14,20],{"label":9,"type":6,"description":10,"interventionNames":11},"Randomized cohort- No stent placement","Participants that are eligible and consent for the randomization cohort of the trial will not have a stent placed.\n\nIf participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.\n\nIn randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.",[12,13],"Other: No stent placement","Other: Surveys",{"label":15,"type":16,"description":17,"interventionNames":18},"Randomized cohort- Stent placement","EXPERIMENTAL","Participants that are eligible and consent for the randomization cohort trial will have a stent placed.\n\nIf participants are found to be ineligible (see below) at the end of ureteroscopy the participants will not be randomized and taken off the study.\n\nIn randomization cohort, second stage eligibility criteria: ureteral perforation, unanticipated anatomic abnormality, greater than expected bleeding, ureteral dilation greater than 12 French, ureteral access sheath utilized, failed ureteroscopy, no or incomplete lithotripsy performed, unable to complete case due to medical or anesthetic event.",[19,13],"Device: Standard of care stent placement",{"label":21,"type":6,"description":22,"interventionNames":23},"Observational participants - not randomized","Patients that do not consent to the randomization trial that elect to be on the observational cohort. Stent placement in the observational cohort will be decided by the surgeon intraoperatively, as per routine clinical practice.",[13],[25,31,35],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DEVICE","Standard of care stent placement","Participants will have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.",[15],null,{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":30},"No stent placement","Participants not have a stent placed per randomization assigned if there are no complications (per protocol) during ureteroscopy that excludes the participant.",[9],{"type":6,"name":36,"description":37,"armGroupLabels":38,"otherNames":30},"Surveys","All participants in the trial cohort and observational arms will be asked to complete survey instruments (evaluating their pain, quality of life, and experiences following ureteroscopy, as well as surveys evaluating their opinions and preferences around ureteral stenting, etc.).\n\nParticipants will also have routine clinical data (preoperative, perioperative, and postoperative) to be collected and analyzed for research purposes.",[21,9,15],[40],{"name":41,"affiliation":5,"role":42},"Khurshid Ghani, MD","PRINCIPAL_INVESTIGATOR",[44,49],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":48},"Elaina Shoemaker","CONTACT","734-764-3916","Esekulos@med.umich.edu",{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},"Sabrina Clark","734-323-9353","sacl@med.umich.edu",[54,74,88,102,115,126,139,152,164,177,190,203,217,230,244,260],{"facility":55,"status":56,"city":57,"state":58,"zip":59,"country":60,"countryCode":61,"cosmosGeoPoint":62,"geoPoint":67,"contacts":68},"University of Arizona","RECRUITING","Tucson","Arizona","85724","United States","US",{"type":63,"coordinates":64},"Point",[65,66],-110.92648,32.22174,{"lat":66,"lon":65},[69,72],{"name":45,"role":46,"phone":70,"phoneExt":30,"email":71},"248-704-9671","esekulos@med.umich.edu",{"name":73,"role":42,"phone":30,"phoneExt":30,"email":30},"David Tzou, MD",{"facility":75,"status":56,"city":76,"state":77,"zip":78,"country":60,"countryCode":61,"cosmosGeoPoint":79,"geoPoint":83,"contacts":84},"UF Health Shands Hospital","Gainesville","Florida","32608",{"type":63,"coordinates":80},[81,82],-82.32483,29.65163,{"lat":82,"lon":81},[85,86],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":87,"role":42,"phone":30,"phoneExt":30,"email":30},"John DiBianco, MD",{"facility":89,"status":56,"city":90,"state":91,"zip":92,"country":60,"countryCode":61,"cosmosGeoPoint":93,"geoPoint":97,"contacts":98},"Indiana University Department of Urology","Indianapolis","Indiana","46202",{"type":63,"coordinates":94},[95,96],-86.15804,39.76838,{"lat":96,"lon":95},[99,100],{"name":45,"role":46,"phone":70,"phoneExt":30,"email":71},{"name":101,"role":42,"phone":30,"phoneExt":30,"email":30},"Marcelino Rivera, MD",{"facility":103,"status":56,"city":104,"state":105,"zip":106,"country":60,"countryCode":61,"cosmosGeoPoint":107,"geoPoint":111,"contacts":112},"University of Michigan Health System","Ann Arbor","Michigan","48111",{"type":63,"coordinates":108},[109,110],-83.74088,42.27756,{"lat":110,"lon":109},[113,114],{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},{"name":41,"role":42,"phone":30,"phoneExt":30,"email":30},{"facility":103,"status":56,"city":116,"state":105,"zip":117,"country":60,"countryCode":61,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"Brighton","48116",{"type":63,"coordinates":119},[120,121],-83.78022,42.52948,{"lat":121,"lon":120},[124,125],{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},{"name":41,"role":42,"phone":30,"phoneExt":30,"email":30},{"facility":127,"status":56,"city":128,"state":105,"zip":129,"country":60,"countryCode":61,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Cadillac Munson Hospital","Cadillac","49601",{"type":63,"coordinates":131},[132,133],-85.40116,44.25195,{"lat":133,"lon":132},[136,137],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":138,"role":42,"phone":30,"phoneExt":30,"email":30},"Laris Galejs, MD",{"facility":140,"status":56,"city":141,"state":105,"zip":142,"country":60,"countryCode":61,"cosmosGeoPoint":143,"geoPoint":147,"contacts":148},"St. Joseph Health System Chelsea Hospital","Chelsea","48118",{"type":63,"coordinates":144},[145,146],-84.02181,42.31807,{"lat":146,"lon":145},[149,150],{"name":45,"role":46,"phone":70,"phoneExt":30,"email":71},{"name":151,"role":42,"phone":30,"phoneExt":30,"email":30},"Andre King, MD",{"facility":153,"status":56,"city":141,"state":105,"zip":142,"country":60,"countryCode":61,"cosmosGeoPoint":154,"geoPoint":156,"contacts":157},"St. Joseph Mercy Health (Trinity)",{"type":63,"coordinates":155},[145,146],{"lat":146,"lon":145},[158,159,163],{"name":50,"role":46,"phone":51,"phoneExt":30,"email":52},{"name":160,"role":46,"phone":161,"phoneExt":30,"email":162},"Casey Dauw, MD","734-936-7030","caseydau@med.umich.edu",{"name":160,"role":42,"phone":30,"phoneExt":30,"email":30},{"facility":165,"status":56,"city":166,"state":105,"zip":167,"country":60,"countryCode":61,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Henry Ford Health System","Detroit","48202",{"type":63,"coordinates":169},[170,171],-83.04575,42.33143,{"lat":171,"lon":170},[174,175],{"name":45,"role":46,"phone":70,"phoneExt":30,"email":71},{"name":176,"role":42,"phone":30,"phoneExt":30,"email":30},"David Leavitt, MD",{"facility":178,"status":56,"city":179,"state":105,"zip":180,"country":60,"countryCode":61,"cosmosGeoPoint":181,"geoPoint":185,"contacts":186},"Corewell Health Buttersworth Hospital","Grand Rapids","49503",{"type":63,"coordinates":182},[183,184],-85.66809,42.96336,{"lat":184,"lon":183},[187,188],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":189,"role":42,"phone":30,"phoneExt":30,"email":30},"Russell Becker, MD",{"facility":191,"status":56,"city":192,"state":105,"zip":193,"country":60,"countryCode":61,"cosmosGeoPoint":194,"geoPoint":198,"contacts":199},"E.W Sparrow Hospital","Lansing","48912",{"type":63,"coordinates":195},[196,197],-84.55553,42.73253,{"lat":197,"lon":196},[200,201],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":202,"role":42,"phone":30,"phoneExt":30,"email":30},"Richard Sarle, MD",{"facility":204,"status":56,"city":205,"state":105,"zip":206,"country":60,"countryCode":61,"cosmosGeoPoint":207,"geoPoint":211,"contacts":212},"MyMichigan Medical Center Midland","Midland","48670",{"type":63,"coordinates":208},[209,210],-84.24721,43.61558,{"lat":210,"lon":209},[213,215],{"name":45,"role":46,"phone":214,"phoneExt":30,"email":71},"736-764-3916",{"name":216,"role":42,"phone":30,"phoneExt":30,"email":30},"Karla Witzke, MD",{"facility":218,"status":56,"city":219,"state":105,"zip":220,"country":60,"countryCode":61,"cosmosGeoPoint":221,"geoPoint":225,"contacts":226},"Michigan Institute of Urology Town Center Ambulatory Surgery Center","Troy","48084",{"type":63,"coordinates":222},[223,224],-83.14993,42.60559,{"lat":224,"lon":223},[227,228],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":229,"role":42,"phone":30,"phoneExt":30,"email":30},"Jason Hafron, MD",{"facility":231,"status":56,"city":232,"state":233,"zip":234,"country":60,"countryCode":61,"cosmosGeoPoint":235,"geoPoint":239,"contacts":240},"Monte Fiore","Brooklyn","New York","10467",{"type":63,"coordinates":236},[237,238],-73.94958,40.6501,{"lat":238,"lon":237},[241,242],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":243,"role":42,"phone":30,"phoneExt":30,"email":30},"Dima Raskolnikov, MD",{"facility":245,"status":56,"city":233,"state":233,"zip":246,"country":60,"countryCode":61,"cosmosGeoPoint":247,"geoPoint":251,"contacts":252},"Mount Sinai","10029",{"type":63,"coordinates":248},[249,250],-74.00597,40.71427,{"lat":250,"lon":249},[253,254,258],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":255,"role":46,"phone":256,"phoneExt":30,"email":257},"Blair Gallante","631-991-1159","blair.gallante@mountsinai.org",{"name":259,"role":42,"phone":30,"phoneExt":30,"email":30},"Mantu Gupta, MD",{"facility":261,"status":56,"city":262,"state":263,"zip":264,"country":60,"countryCode":61,"cosmosGeoPoint":265,"geoPoint":269,"contacts":270},"UNC Hospital","Chapel Hill","North Carolina","27514",{"type":63,"coordinates":266},[267,268],-79.05584,35.9132,{"lat":268,"lon":267},[271,272],{"name":45,"role":46,"phone":47,"phoneExt":30,"email":71},{"name":273,"role":42,"phone":30,"phoneExt":30,"email":30},"David Friedlander, MD",{"type":42,"investigatorFullName":275,"investigatorTitle":276,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"Khurshid Ghani","Professor of Urology",[278,280],{"name":279,"class":6},"Patient-Centered Outcomes Research Institute",{"name":281,"class":6},"Michigan Urological Surgery Improvement Collaborative (MUSIC)","100505799","stent-omission-after-ureteroscopy-and-lithotripsy-in-the-michigan-urological-surgery-improvement-collaborative-100505799",false,"NCT05866081","Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative","Stent Omission After Ureteroscopy and Lithotripsy in the Michigan Urological Surgery Improvement Collaborative (SOUL MUSIC)","Inclusion Criteria:\n\n* Undergoing unilateral ureteroscopy and lithotripsy for stone disease (participants may have contralateral stones, as long as these are asymptomatic and not being treated concurrently)\n* Largest stone less or equal to 10 millimeter in size as measured on abdominal x-ray, ultrasound, or computed tomography scan\n* Access to means of communication with the study team (email, text messaging, and\u002For telephone)\n* Adequate independent cognitive function and English language proficiency to complete study surveys\n* Written informed consent\n\nExclusion Criteria:\n\n* Planned bilateral ureteroscopy\n* Indwelling ureteral stent or percutaneous nephrostomy tube preoperatively in either kidney\n* Anatomic abnormalities of the ipsilateral upper urinary tract (for example, horseshoe kidney, crossed fused ectopia, pelvic kidney, urinary diversion)\n* Anatomic or functional solitary kidney\n* Planned secondary or staged ureteroscopy\n* Planned use of ureteral access sheath\n* Pregnancy\n* Patients who use opiate medication daily for greater than 3 months to manage a painful condition\n\nSecond Stage Exclusion Criteria:\n\n* ureteral perforation\n* unanticipated anatomic abnormality\n* greater than expected bleeding\n* ureteral dilation greater than 12 French\n* ureteral access sheath utilized\n* failed ureteroscopy\n* no or incomplete lithotripsy performed\n* unable to complete case due to medical or anesthetic event.","ALL","18 Years",{"count":292,"type":293},792,"ESTIMATED","INTERVENTIONAL",[296],"NA","This is a multicenter prospective trial with randomized and observational cohorts assessing patient-reported outcomes and unplanned healthcare utilization following ureteroscopic treatment of renal and ureteral stones, with placement versus omission of a ureteral stent.\n\nEligible participants in the randomization trial will be randomized to ureteroscopy with stent placement or stent omission.\n\nEligible participants that consent to the observational only cohort will complete surveys and the treating physicians will decide the treatment options for the participants.\n\nThe study team hypothesizes that:\n\n* Pain interference change from pre-surgery to Day 7-10 will differ between the two treatment arms. This hypothesis will be evaluated separately in the randomized and observational cohorts.\n* Unplanned healthcare utilization in the treatment arms will have different unplanned healthcare utilization ranks leading to a win proportion significantly higher or lower than 0.5 in the stent omission arm compared to the stent placement arm. This hypothesis will be evaluated separately in the randomized and observational cohorts.",[299,300],"Stone, Kidney","Stone Ureter",[302,303,304,305],"Unilateral ureteroscopy and lithotripsy","Ureteral stent","Pain assessment","Quality of life","2025-12-08",{"date":308,"type":309},"2025-12-15","ACTUAL",{"date":311,"type":309},"2023-06-01",{"date":313,"type":293},"2026-05-01",{"name":5,"class":6},16]