[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100352776":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":64,"collaborators":67,"id":73,"slug":20,"hasResults":74,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":20,"eligibilityCriteria":78,"healthyVolunteers":74,"sex":79,"minAge":80,"maxAge":20,"enrollmentInfo":81,"targetDuration":20,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":20,"overallStatus":37,"whyStopped":20,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"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",[35,51],{"facility":36,"status":37,"city":38,"state":39,"zip":40,"country":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"IU Health North Hospital","RECRUITING","Carmel","Indiana","46032","United States",{"type":43,"coordinates":44},"Point",[45,46],-86.11804,39.97837,{"lat":46,"lon":45},[49],{"name":50,"role":27,"phone":20,"phoneExt":20,"email":20},"Kimberly Smoot",{"facility":52,"status":37,"city":53,"state":54,"zip":55,"country":41,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"University of Washington Medical Center","Seattle","Washington","98195",{"type":43,"coordinates":57},[58,59],-122.33207,47.60621,{"lat":59,"lon":58},[62],{"name":63,"role":27,"phone":20,"phoneExt":20,"email":20},"Barbara Burke",{"type":24,"investigatorFullName":65,"investigatorTitle":66,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Jonathan Harper, MD","Adjunct Professor, Surgery",[68,70],{"name":69,"class":6},"Indiana University",{"name":71,"class":72},"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":82,"type":83},40,"ESTIMATED","INTERVENTIONAL",[86],"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.",[89,90],"Renal Calculi","Ureteral Calculi","2026-05-10",{"date":93,"type":94},"2026-05-13","ACTUAL",{"date":96,"type":94},"2019-08-08",{"date":98,"type":83},"2028-04-30",{"name":5,"class":6},2]