[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100610759":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":25,"centralContacts":33,"locations":42,"responsibleParty":59,"collaborators":10,"id":61,"slug":62,"hasResults":63,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":10,"eligibilityCriteria":67,"healthyVolunteers":63,"sex":68,"minAge":69,"maxAge":10,"enrollmentInfo":70,"targetDuration":10,"studyType":73,"phases":10,"briefSummary":74,"conditions":75,"keywords":10,"overallStatus":45,"whyStopped":10,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"ReCor Medical, Inc.","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Exposure Group (uRDN + SOC)",null,"A procedure or device code for the Paradise™ ultrasound renal denervation system (uRDN) and medication records indicating receipt of blood pressure-lowering medications.",[13],"Device: Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)",{"label":15,"type":10,"description":16,"interventionNames":10},"Comparator Group (SOC)","Medication records indicating receipt of blood pressure-lowering medications.",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Ultrasound Renal Denervation (Paradise™ Ultrasound Renal Denervation (uRDN) System)","A catheter-based system that delivers ultrasound energy to the renal sympathetic nerves.",[9],[24],"Paradise™ ultrasound renal denervation system",[26,30],{"name":27,"affiliation":28,"role":29},"Megan Coylewright, MD","Essentia Health","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Amir Kaki, MD","Ascension St. John Hospital",[34,39],{"name":35,"role":36,"phone":37,"phoneExt":10,"email":38},"Helen Reeve-Stoffer, Ph.D","CONTACT","650-542-7700","hreeve-stoffer@recormedical.com",{"name":40,"role":36,"phone":37,"phoneExt":10,"email":41},"Elizabeth A Sheehan, MLIS, MA","liz.sheehan@recormedical.com",[43],{"facility":44,"status":45,"city":46,"state":47,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Henry Ford St. John Hospital","RECRUITING","Detroit","Michigan","48236","United States","US",{"type":52,"coordinates":53},"Point",[54,55],-83.04575,42.33143,{"lat":55,"lon":54},[58],{"name":31,"role":36,"phone":10,"phoneExt":10,"email":10},{"type":60,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100610759","the-radiance-ced-study-100610759",false,"NCT07231757","The RADIANCE CED Study","The Recor Paradise System™ Hypertension Coverage With Evidence Development Study","Common Inclusion Criteria:\n\n* Adults aged ≥65 years with uncontrolled hypertension\n* Stable regimen of blood pressure-lowering medication\n\nCommon Exclusion Criteria:\n\n* Hypertension due to secondary causes\n* Prior renal denervation treatment\n* Pregnancy\n* End-stage renal disease, dialysis, or kidney transplant","ALL","65 Years",{"count":71,"type":72},1000,"ESTIMATED","OBSERVATIONAL","The RADIANCE CED study is a prospective observational study designed to evaluate the long-term effectiveness of ultrasound renal denervation in lowering blood pressure among patients with uncontrolled hypertension. Data will be collected from electronic health records (EHRs) of Medicare-eligible patients to support generalizability of outcomes to the broader Medicare population. Individual hospital enrollment is not required for this study and IRB exemption has been received by sponsor.",[76,77,78],"Hypertension","Cardiovascular Diseases","Vascular Diseases","2026-01-07",{"date":81,"type":82},"2026-01-09","ACTUAL",{"date":84,"type":82},"2025-11-21",{"date":86,"type":72},"2031-12-31",{"name":5,"class":6},1]