[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636541":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":53,"collaborators":21,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":60,"acronym":21,"eligibilityCriteria":61,"healthyVolunteers":57,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":21,"studyType":68,"phases":69,"briefSummary":71,"conditions":72,"keywords":75,"overallStatus":42,"whyStopped":21,"lastUpdateSubmitDate":79,"lastUpdatePostDateStruct":80,"startDateStruct":83,"completionDateStruct":85,"leadSponsor":87,"locationsCount":88},{"fullName":5,"class":6},"NYU Langone Health","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Barrigel Placement","EXPERIMENTAL","Each subject will undergo transperineal ultrasound-guided Barrigel placement prior to their image-guided prostate cryoablation in the same procedure session.",[13,14],"Device: Barrigel Injectable Gel","Procedure: Cryoablation",[16,22],{"type":17,"name":18,"description":19,"armGroupLabels":20,"otherNames":21},"DEVICE","Barrigel Injectable Gel","Barrigel is a hyaluronic acid-based absorbable perirectal spacer.",[9],null,{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":21},"PROCEDURE","Cryoablation","Minimally invasive treatment for both localized and recurrent prostate cancer.",[9],[28],{"name":29,"affiliation":5,"role":30},"Wei Phin Tan, MD","PRINCIPAL_INVESTIGATOR",[32,37],{"name":33,"role":34,"phone":35,"phoneExt":21,"email":36},"Viola Sulollari","CONTACT","(646) 825-6300","Viola.Sulollari@nyulangone.org",{"name":29,"role":34,"phone":38,"phoneExt":21,"email":39},"646-825-6325","weiphin.tan@nyulangone.org",[41],{"facility":5,"status":42,"city":43,"state":43,"zip":44,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":21},"RECRUITING","New York","10016","United States","US",{"type":48,"coordinates":49},"Point",[50,51],-74.00597,40.71427,{"lat":51,"lon":50},{"type":54,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","100636541","improving-cryoablation-efficacy-with-barrigel-rectal-spacing-ice-barr-100636541",false,"NCT07567027","Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR)","Improving Cryoablation Efficacy With BARRigel Rectal Spacing (ICE-BARR) Trial","Inclusion Criteria:\n\n* Male patients aged 40-95 years.\n* Biopsy-confirmed localized prostate cancer (Grade Group ≥ 2). Salvage cryoablation cases may be included.\n* Unifocal disease visible on multiparametric MRI (mpMRI) and amenable to focal or whole gland cryoablation.\n* Prostate-specific antigen (PSA) \\\u003C 20 ng\u002Fml.\n* No metastatic disease on Prostate-Specific Membrane Antigen (PSMA) PET\u002FCT, when recommended per National Comprehensive Cancer Network (NCCN) guidelines.\n* Eligible for and consenting to transperineal cryoablation under anesthesia.\n* Willingness to comply with post-procedure follow-up, including PSA testing and imaging.\n* Cryoablation which requires treatment of the posterior prostate as per clinician judgement.\n\nExclusion Criteria:\n\n* Evidence of metastatic disease.\n* Prior radiation therapy to the area of the prostate.\n* Active rectal or urinary tract infection.\n* Known allergy to hyaluronic acid products or contrast agents.\n* Inability to tolerate MRI.\n* Inability or unwillingness to comply with study follow-up.","MALE","40 Years","95 Years",{"count":66,"type":67},20,"ESTIMATED","INTERVENTIONAL",[70],"NA","The purpose of this study is to evaluate the feasibility, safety, and potential protective benefit of Barrigel, a hyaluronic acid-based rectal spacer, in patients undergoing prostate cryoablation for localized or recurrent prostate cancer. The primary aim is to assess Barrigel thermal stability during cryoablation.",[73,74],"Prostate Cancer (Diagnosis)","Transperineal Cryoablation",[76,77,78],"cryoablation","prostate","Barrigel","2026-07-07",{"date":81,"type":82},"2026-07-09","ACTUAL",{"date":84,"type":82},"2026-06-17",{"date":86,"type":67},"2028-06-01",{"name":5,"class":6},1]