[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100352776":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":65,"collaborators":68,"id":74,"slug":20,"hasResults":75,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":20,"eligibilityCriteria":79,"healthyVolunteers":75,"sex":80,"minAge":81,"maxAge":20,"enrollmentInfo":82,"targetDuration":20,"studyType":85,"phases":86,"briefSummary":88,"conditions":89,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"University of Washington","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Treatment Group","EXPERIMENTAL","Subjects in this arm receive the 10-minute burst wave lithotripsy intervention dose during their standard-of-care lithotripsy procedure.",[13],"Device: Burst Wave Lithotripsy",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Burst Wave Lithotripsy","Fragment upper urinary tract stones",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Michael R Bailey, PhD, MS","PRINCIPAL_INVESTIGATOR",[26,30],{"name":23,"role":27,"phone":28,"phoneExt":20,"email":29},"CONTACT","206-619-2035","mbailey@uw.edu",{"name":31,"role":27,"phone":32,"phoneExt":20,"email":33},"Barbrina Dunmire","206-769-5910","mrbean@uw.edu",[35,52],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"IU Health North Hospital","RECRUITING","Carmel","Indiana","46032","United States","US",{"type":44,"coordinates":45},"Point",[46,47],-86.11804,39.97837,{"lat":47,"lon":46},[50],{"name":51,"role":27,"phone":20,"phoneExt":20,"email":20},"Kimberly Smoot",{"facility":53,"status":37,"city":54,"state":55,"zip":56,"country":41,"countryCode":42,"cosmosGeoPoint":57,"geoPoint":61,"contacts":62},"University of Washington Medical Center","Seattle","Washington","98195",{"type":44,"coordinates":58},[59,60],-122.33207,47.60621,{"lat":60,"lon":59},[63],{"name":64,"role":27,"phone":20,"phoneExt":20,"email":20},"Barbara Burke",{"type":24,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jonathan Harper, MD","Adjunct Professor, Surgery",[69,71],{"name":70,"class":6},"Indiana University",{"name":72,"class":73},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100352776",false,"NCT03873259","Intraoperative Assessment of of Burst Wave Lithotripsy (BWL)","Burst Wave Lithotripsy (BWL) for the Comminution of Urinary Tract Stones: Intraoperative Evaluation of Safety and Effectiveness","Inclusion Criteria:\n\n* Individuals presenting with at least one kidney stone apparent on CT\n* Individuals scheduled for clinical stone removal via ureteroscopy (URS)\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.)\n* Individuals with uncorrected bleeding disorders or coagulopathies\n* Individuals taking a clinically significant anticoagulant dose at the time of the procedure\n* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm\n* Individuals with a solitary kidney\n* Individuals with a comorbidity risks which, at the discretion of the physician, would make the patient a poor candidate for the BWL procedure","ALL","18 Years",{"count":83,"type":84},40,"ESTIMATED","INTERVENTIONAL",[87],"NA","Burst Wave Lithotripsy (BWL) is a novel method of urinary stone fragmentation that uses multi-cycle bursts of low amplitude ultrasound to induce stone fracture. This is in contrast to traditional extracorporeal shock wave lithotripsy (SWL), which employs a brief single compression\u002Ftensile cycle of high amplitude (shock) waves to achieve stone fracture. This is a single-arm feasibility study to test the ability of BWL to comminute (fragment) stones in humans.",[90,91],"Renal Calculi","Ureteral Calculi","2026-05-10",{"date":94,"type":95},"2026-05-13","ACTUAL",{"date":97,"type":95},"2019-08-08",{"date":99,"type":84},"2028-04-30",{"name":5,"class":6},2]