[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636541":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":52,"collaborators":21,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":21,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":21,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":78,"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":21,"city":42,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":21},"New York","10016","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-74.00597,40.71427,{"lat":50,"lon":49},{"type":53,"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":65,"type":66},20,"ESTIMATED","INTERVENTIONAL",[69],"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.",[72,73],"Prostate Cancer (Diagnosis)","Transperineal Cryoablation",[75,76,77],"cryoablation","prostate","Barrigel","NOT_YET_RECRUITING","2026-04-28",{"date":81,"type":82},"2026-05-05","ACTUAL",{"date":84,"type":66},"2026-06-01",{"date":86,"type":66},"2028-06-01",{"name":5,"class":6},1]