[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607455":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":18,"centralContacts":27,"locations":37,"responsibleParty":71,"collaborators":18,"id":74,"slug":75,"hasResults":76,"nctId":77,"briefTitle":78,"officialTitle":78,"acronym":79,"eligibilityCriteria":80,"healthyVolunteers":76,"sex":81,"minAge":82,"maxAge":83,"enrollmentInfo":84,"targetDuration":18,"studyType":87,"phases":88,"briefSummary":90,"conditions":91,"keywords":93,"overallStatus":60,"whyStopped":18,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"locationsCount":107},{"fullName":5,"class":6},"Rutgers, The State University of New Jersey","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"RADA16","ACTIVE_COMPARATOR","Patients randomized to the treatment arm will undergo application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.",[13],"Device: RADA16 hydrogel",{"label":15,"type":16,"description":17,"interventionNames":18},"Control arm","NO_INTERVENTION","Patients randomized to the control arm will not undergo application of RADA16 hydrogel following hemostasis with suction monopolar electrocautery.",null,[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DEVICE","RADA16 hydrogel","Application of 2.5% RADA16 hydrogel to the tonsillar fossae following tonsillectomy using a sterile syringe tip applicator. The gel will be spread into a thin layer within the tonsillar fossae. The gel will be left to sit for 60 seconds. A suction device will then be used to remove any excess RADA16 hydrogel, leaving a thin layer of RADA16 over the tonsillar fossae.",[9],[26],"puragel",[28,33],{"name":29,"role":30,"phone":31,"phoneExt":18,"email":32},"Wayne D Hsueh, MD","CONTACT","973-972-4588","wayne.hsueh@rutgers.edu",{"name":34,"role":30,"phone":35,"phoneExt":18,"email":36},"Gabriel Frimpong, MPH, PA","973-972-2309","gf345@njms.rutgers.edu",[38,58],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Cooperman Barnabas Medical Center","NOT_YET_RECRUITING","Livingston","New Jersey","07039","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.31487,40.79593,{"lat":50,"lon":49},[53,55],{"name":29,"role":30,"phone":54,"phoneExt":18,"email":32},"9739722548",{"name":56,"role":57,"phone":18,"phoneExt":18,"email":18},"Wayne Hsueh, MD","PRINCIPAL_INVESTIGATOR",{"facility":59,"status":60,"city":61,"state":42,"zip":62,"country":44,"countryCode":45,"cosmosGeoPoint":63,"geoPoint":67,"contacts":68},"University Hospital","RECRUITING","Newark","07103",{"type":47,"coordinates":64},[65,66],-74.17237,40.73566,{"lat":66,"lon":65},[69,70],{"name":29,"role":30,"phone":54,"phoneExt":18,"email":32},{"name":56,"role":57,"phone":18,"phoneExt":18,"email":18},{"type":57,"investigatorFullName":72,"investigatorTitle":73,"investigatorAffiliation":5,"oldNameTitle":18,"oldOrganization":18},"Wayne Daniel Hsueh, MD","ASSOC PROF-CLIN","100607455","phase-2-impact-of-rada16-use-on-outcomes-following-tonsillectomy-in-children-100607455",false,"NCT07188779","Impact of RADA16 Use on Outcomes Following Tonsillectomy in Children","RADA16 for Ped","Inclusion Criteria:\n\nChildren aged 3-17 years undergoing tonsillectomy +\u002F- adenoidectomy CPT codes\n\n* 42820 (Tonsillectomy and adenoidectomy; younger than age 12)\n* 42821 (… age 12 or over)\n* 42825 (Tonsillectomy; primary or secondary; younger than age 12)\n* 42826 (… age 12 or over)\n* 42830 (Adenoidectomy, primary; younger than age 12)\n* 42831 (… age 12 or over)\n* 42835 (Adenoidectomy; secondary; younger than age 12)\n* 42836 (… age 12 or over)\n\nExclusion Criteria:\n\n* Children with bleeding disorders or other hematologic malignancy or taking anticoagulant medications Developmental delay affecting pain reporting Children with known allergies to RADA16 components Children with prior tonsillectomy or tonsillotomy Children undergoing tonsillectomy with concern for cancer, Children taking opioids chronically prior to surgery, Anyone pregnant women, incarcerated individuals, children unable to speak English or Spanish","ALL","3 Years","17 Years",{"count":85,"type":86},134,"ESTIMATED","INTERVENTIONAL",[89],"PHASE2","The purpose of the research is to determine if RADA16 (also known as PuraStat®, PuraGel®, or PuraSinus®) improves patient outcomes following pediatric tonsillectomy procedures. Researchers will compare application of device RADA16 to application of no device to see if RADA16 works to treat post tonsillectomy hemorrhage.Participants will:\n\nUndergo tonsillectomy procedure. Receive and fill out a survey sent via email every 2 days following their procedure for 15 days, plus an additional survey on day 30, and track their symptoms.",[92],"Postoperative Pain",[94,95,96,97],"tonsillectomy","adenoidectomy","hemostasis","postop complications","2026-06-07",{"date":100,"type":101},"2026-06-09","ACTUAL",{"date":103,"type":86},"2026-07-01",{"date":105,"type":86},"2027-12-01",{"name":5,"class":6},2]