[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653758":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":45,"studyPopulation":35,"armGroups":46,"interventions":57,"overallOfficials":63,"centralContacts":67,"locations":73,"responsibleParty":101,"collaborators":104,"id":108,"slug":109,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":110,"sex":116,"minAge":117,"maxAge":35,"enrollmentInfo":118,"targetDuration":35,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":128,"overallStatus":76,"whyStopped":35,"lastUpdateSubmitDate":132,"lastUpdatePostDateStruct":133,"startDateStruct":136,"completionDateStruct":138,"leadSponsor":140,"locationsCount":141},{"fullName":5,"class":6},"Endeavor Health","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Hematuria grade at 1-3 hours postop in the PACU","Grade the amount of blood present 1-3 hours after surgery Scale zero through Five","1 to 3 hours post procedure",[14,18,22,25,28,31],{"measure":15,"description":16,"timeFrame":17},"Percentage of patients discharged on the same day","Examine whether the device helps recover more quickly and be discharged the same day, which currently happens in only 1% of cases.","Postoperative Week 1",{"measure":19,"description":20,"timeFrame":21},"Patient Reported Outcome Measure IPSS questionnaire","International Prostate Symptom Score (IPSS), Min 0 Max 35 (Worst symptoms)","From Enrollment to 30 days post procedure",{"measure":23,"description":24,"timeFrame":21},"Patient Reported Outcome Measures LURN SI-29 questionnaire","Lower Urinary Research Network Symptom Index-29. Max 100 (Worst Symptoms), Min 0 (Best Symptoms). Multiple health domains are being evaluated such as incontinence, pain, voiding, urgency, nocturia, frequency",{"measure":26,"description":27,"timeFrame":21},"Patient Reported Outcome Measures SHIM questionnaire","Sexual health inventory for men, Min 1 (Worst Sexual health) Max 25 ( Best Sexual Health)",{"measure":29,"description":30,"timeFrame":21},"Patient Reported Outcome Measures MSHQ-EjD questionnaire","Male Sexual Health Questionnaire - Ejaculatory Dysfunction, Min 1 ( Worst) Max 15 ( Best)",{"measure":32,"description":33,"timeFrame":34},"Patient Reported Outcome Measures Dysuria questionnaire","Difficult urination, Min 0 Max 5 (Worst)","30 days post procedure",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","PuraStat and non PuraStat","SUPPORTIVE_CARE",{"masking":42,"maskingDescription":35,"whoMasked":43},"SINGLE",[44],"PARTICIPANT","This study will evaluate the safety and effectiveness of a device (PuraStat hydrogel and the syringe used to apply it - referred to as PuraStat, designed to help control bleeding after the subject's scheduled Aquablation procedure. To assess its effectiveness, investigators will take a picture of the color of your urethral Foley catheter and grade the amount of blood present 1-3 hours after surgery. Investigators will also examine whether the device helps subjects recover more quickly and be discharged the same day, which currently happens in only 1% of cases.",[47,51],{"label":48,"type":49,"description":50,"interventionNames":35},"No PuraStat after the Aquablation procedure","NO_INTERVENTION","Patient will not receive PuraStat after the Aquablation procedure",{"label":52,"type":53,"description":54,"interventionNames":55},"PuraStat after the Aquablation procedure","EXPERIMENTAL","Receive PuraStat after the Aquablation procedure",[56],"Device: PuraStat hydrogel and the syringe",[58],{"type":59,"name":60,"description":61,"armGroupLabels":62,"otherNames":35},"DEVICE","PuraStat hydrogel and the syringe","PuraStat device is FDA-approved for other uses, such as gastrointestinal endoscopy and ENT (ear, nose, throat) procedures. Its use in this study for urology is investigational.",[52],[64],{"name":65,"affiliation":5,"role":66},"Alexander P Glaser, MD","STUDY_DIRECTOR",[68],{"name":69,"role":70,"phone":71,"phoneExt":35,"email":72},"Pooja Research Manager, MS MHA","CONTACT","847-503-34280","PTalaty@northshore.org",[74],{"facility":75,"status":76,"city":77,"state":78,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Glenbrook Hospital- Endeavor Health","RECRUITING","Glenview","Illinois","60026","United States","US",{"type":83,"coordinates":84},"Point",[85,86],-87.78784,42.06975,{"lat":86,"lon":85},[89,92,95,97,99],{"name":90,"role":70,"phone":91,"phoneExt":35,"email":72},"Pooja Talaty, MS MHA","847-503-4280",{"name":93,"role":94,"phone":35,"phoneExt":35,"email":35},"Brian T Helfand, MD PhD","PRINCIPAL_INVESTIGATOR",{"name":65,"role":96,"phone":35,"phoneExt":35,"email":35},"SUB_INVESTIGATOR",{"name":98,"role":96,"phone":35,"phoneExt":35,"email":35},"James T Kearns, MD",{"name":100,"role":96,"phone":35,"phoneExt":35,"email":35},"Andrew Higgins, MD",{"type":94,"investigatorFullName":102,"investigatorTitle":103,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Alexander Glaser","Vice Chief of Urology and Director of Urology Research, Endeavor Health",[105],{"name":106,"class":107},"PROCEPT BioRobotics","INDUSTRY","100653758","use-of-purastat-following-aquablation-to-determine-if-there-is-change-in-hematuria--probability-of-same-day-discharge-100653758",false,"NCT07789041","Use of PuraStat Following Aquablation to Determine if There is Change in Hematuria & Probability of Same Day Discharge","PuraStat for Aquablation Day Case (Use of PuraStat Following an Aquablation Procedure)","PuraStat","Inclusion Criteria:\n\n1. Subject must be undergoing Aquablation\n2. Subject is willing to comply with protocol requirements\n\nExclusion Criteria:\n\n1. Any significant medical condition which, in the attending physician's opinion, may interfere with the patient's optimal procedure\n2. Known or suspected systemic or severe infection\n3. Patient unable to give consent","MALE","18 Years",{"count":119,"type":120},50,"ESTIMATED","INTERVENTIONAL",[123],"NA","Randomized, single-blinded investigational study to assess the safety of PuraStat following the Aquablation procedure",[126,127],"BPH (Benign Prostatic Hyperplasia)","BPH With Symptomatic Lower Urinary Tract Symptoms",[129,130,131],"PuraStat,Aquablation","BPH","Lower urinary tract symptoms","2026-08-24",{"date":134,"type":135},"2026-08-27","ACTUAL",{"date":137,"type":135},"2025-08-12",{"date":139,"type":120},"2026-12-12",{"name":5,"class":6},1]