[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100423662":3},{"organization":4,"armGroups":7,"interventions":27,"overallOfficials":33,"centralContacts":37,"locations":46,"responsibleParty":89,"collaborators":91,"id":99,"slug":100,"hasResults":101,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":22,"eligibilityCriteria":105,"healthyVolunteers":106,"sex":107,"minAge":108,"maxAge":22,"enrollmentInfo":109,"targetDuration":22,"studyType":112,"phases":113,"briefSummary":115,"conditions":116,"keywords":22,"overallStatus":63,"whyStopped":22,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":123,"completionDateStruct":125,"leadSponsor":127,"locationsCount":128},{"fullName":5,"class":6},"University of Washington","OTHER",[8,14,18,23],{"label":9,"type":10,"description":11,"interventionNames":12},"Phase I: Feasibility Treatment group","EXPERIMENTAL","Initial phase of the trial to demonstrate feasibility. All subjects undergo the investigational intervention.",[13],"Device: Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)",{"label":15,"type":10,"description":16,"interventionNames":17},"Phase 2a: Treatment Group of a randomized control trial","RCT phase of the trial to demonstrate superiority. All subjects undergo the investigational intervention.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Phase 2a: Control group of a randomized control trial","NO_INTERVENTION","RCT phase of the trial to demonstrate superiority. All subjects are the concurrent Control to the Phase 2a Treatment group. Subjects receive no intervention.",null,{"label":24,"type":10,"description":25,"interventionNames":26},"Phase 2b: Spinal Cord Injury Feasibility Study","Feasbility study of the investigational intervention in subjects with spinal cord injury.",[13],[28],{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":22},"DEVICE","Burst Wave Lithotripsy (BWL) and Ultrasonic Propulsion (UP)","Novel ultrasound technologies to facilitate passage of stones.This includes Burst Wave Lithotripsy (BWL), a technology to noninvasively fragment urinary calculi within the kidney and ureter, and ultrasonic propulsion, a technology to non-invasively reposition stones within the kidney and ureter. BWL uses short 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. Ultrasonic propulsion uses long multi-cycle bursts of low amplitude ultrasound to move stones within the collecting system.",[15,24,9],[34],{"name":35,"affiliation":5,"role":36},"Jonathan Harper, MD","PRINCIPAL_INVESTIGATOR",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},"Michael Bailey, PhD","CONTACT","206-619-2035","mbailey@uw.edu",{"name":44,"role":40,"phone":22,"phoneExt":22,"email":45},"Barbrina Dunmire, MS","mrbean@uw.edu",[47,61,78],{"facility":48,"status":49,"city":50,"state":51,"zip":52,"country":53,"countryCode":54,"cosmosGeoPoint":55,"geoPoint":60,"contacts":22},"Indiana University Health - North Hospital","WITHDRAWN","Carmel","Indiana","46032","United States","US",{"type":56,"coordinates":57},"Point",[58,59],-86.11804,39.97837,{"lat":59,"lon":58},{"facility":62,"status":63,"city":64,"state":65,"zip":66,"country":53,"countryCode":54,"cosmosGeoPoint":67,"geoPoint":71,"contacts":72},"VA Puget Sound Health Care System","RECRUITING","Seattle","Washington","98108",{"type":56,"coordinates":68},[69,70],-122.33207,47.60621,{"lat":70,"lon":69},[73,76],{"name":74,"role":40,"phone":22,"phoneExt":22,"email":75},"Branda Levchak","branda.levchak@va.gov",{"name":77,"role":36,"phone":22,"phoneExt":22,"email":22},"Claire Yang, MD",{"facility":5,"status":63,"city":64,"state":65,"zip":79,"country":53,"countryCode":54,"cosmosGeoPoint":80,"geoPoint":82,"contacts":83},"98195",{"type":56,"coordinates":81},[69,70],{"lat":70,"lon":69},[84,85,88],{"name":39,"role":40,"phone":41,"phoneExt":22,"email":42},{"name":86,"role":40,"phone":22,"phoneExt":22,"email":87},"Barbara Burke","burkeb3@uw.edu",{"name":35,"role":36,"phone":22,"phoneExt":22,"email":22},{"type":36,"investigatorFullName":35,"investigatorTitle":90,"investigatorAffiliation":5,"oldNameTitle":22,"oldOrganization":22},"Associate Professor, School of Medicine",[92,94,96],{"name":93,"class":6},"Indiana University",{"name":62,"class":95},"FED",{"name":97,"class":98},"National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)","NIH","100423662","ultrasound-to-facilitate-stone-passage-100423662",false,"NCT04796792","Ultrasound to Facilitate Stone Passage","Ultrasound Technology to Fragment and Reposition Urinary Stones","Inclusion Criteria:\n\n* Individuals presenting with at least one kidney stone\n* Stone with maximum dimension \\> 2 mm and ≤ 7 mm as determined by clinical imaging\n* Individuals with SCI - (Phase 2b only)\n\nExclusion Criteria:\n\n* Individuals under 18 years of age\n* Individuals who are pregnant or who are trying to get pregnant\n* Prisoners\n* with cognitive impairment that would limit their ability to comprehend their role in consent or participation.\n* Individuals who are unable to read or understand English\n* Individuals who are unable or unwilling to participate in follow up activities\n* Individuals who cannot be positioned for ultrasound imaging\n* Individuals with uncorrected bleeding disorders or coagulopathies\n* Individuals receiving anticoagulants and who are unable or not willing to temporarily cease the medication for the investigational procedure\n* Individuals with a calcified abdominal aortic aneurysm or calcified renal artery aneurysm ipsilateral to the renal stone targeted by the investigational procedure\n* Individuals with a solitary kidney\n* Individuals with an uncorrected urinary tract obstruction\n* Individuals with an untreated infection\n* Individuals with a comorbidity risk which, at the discretion of the physician, would make the patient a poor candidate for the investigational procedure\n* Individuals who have received two previous investigational procedures for the same stone target\n* Individuals who have undergone the investigational procedure within the last 21 days or still have unresolved AEs from a previous investigational procedure.",true,"ALL","18 Years",{"count":110,"type":111},140,"ESTIMATED","INTERVENTIONAL",[114],"NA","This is a prospective, open-label, multi-center study to test the clinical feasibility of facilitating stone passage by the combination of breaking and repositioning stones with ultrasound, without the need for anesthesia.",[117,118],"Urinary Stone","Urinary Calculi","2025-12-02",{"date":121,"type":122},"2025-12-09","ACTUAL",{"date":124,"type":122},"2023-04-01",{"date":126,"type":111},"2028-10-31",{"name":5,"class":6},3]