[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588970":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":25,"locations":34,"responsibleParty":46,"collaborators":20,"id":48,"slug":49,"hasResults":50,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":50,"sex":56,"minAge":20,"maxAge":20,"enrollmentInfo":57,"targetDuration":20,"studyType":60,"phases":61,"briefSummary":63,"conditions":64,"keywords":20,"overallStatus":68,"whyStopped":20,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":78},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Men Undergoing Aquablation","EXPERIMENTAL","Following the Aquablation procedure for lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH), the surgeon will deliver the PuraStat to the prostatic fossa through the cystoscope sheath into the prostate urethra resection bed.",[13],"Device: PuraStat",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","PuraStat","Sterile gel composed of synthetic peptide and sterile water; provided as a prefilled syringe. The will be applied to the inside of the prostate to help stop bleeding following Aquablation.",[9],null,[22],{"name":23,"affiliation":5,"role":24},"Christopher Kelly, MD","PRINCIPAL_INVESTIGATOR",[26,31],{"name":27,"role":28,"phone":29,"phoneExt":20,"email":30},"Majlinda Tafa, MD","CONTACT","(646) 825-6338","majlinda.tafa@nyulangone.org",{"name":23,"role":28,"phone":32,"phoneExt":20,"email":33},"(646) 754-2462","chris.kelly@nyulangone.org",[35],{"facility":5,"status":20,"city":36,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":20},"New York","10016","United States","US",{"type":41,"coordinates":42},"Point",[43,44],-74.00597,40.71427,{"lat":44,"lon":43},{"type":47,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100588970","phase-2-rada16-for-aquablation-day-case-100588970",false,"NCT06948331","RADA16 for Aquablation Day Case","A Pilot Proof of Concept Single-arm Study Using PuraStat Following the Aquablation Procedure to Assess Reduction of Hematuria to Allow for Same Day Discharge","RAD","Inclusion Criteria:\n\n• Any man undergoing Aquablation for LUTS due to BPH\n\nExclusion Criteria:\n\n• Unwilling to sign consent","MALE",{"count":58,"type":59},25,"ESTIMATED","INTERVENTIONAL",[62],"PHASE2","This is a pilot proof of concept single-arm study using PuraStat following Aquablation procedure to assess reduction of hematuria to allow for same day discharge.\n\nThe primary objective is to assess how PuraStat affects post-operative hematuria following Aquablation.\n\nThe secondary objective is to assess the number of patients discharged on the same day based on the hematuria criteria (Grade 0 and Grade I).",[65,66,67],"Hematuria","Benign Prostatic Hyperplasia","Lower Urinary Tract Symptoms","NOT_YET_RECRUITING","2026-02-25",{"date":71,"type":72},"2026-02-27","ACTUAL",{"date":74,"type":59},"2026-04-01",{"date":76,"type":59},"2026-08-01",{"name":5,"class":6},1]