[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100636541":3},{"organization":4,"armGroups":7,"interventions":15,"overallOfficials":27,"centralContacts":31,"locations":40,"responsibleParty":51,"collaborators":21,"id":53,"slug":21,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":21,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":21,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":76,"whyStopped":21,"lastUpdateSubmitDate":77,"lastUpdatePostDateStruct":78,"startDateStruct":81,"completionDateStruct":83,"leadSponsor":85,"locationsCount":86},{"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,"cosmosGeoPoint":45,"geoPoint":50,"contacts":21},"New York","10016","United States",{"type":46,"coordinates":47},"Point",[48,49],-74.00597,40.71427,{"lat":49,"lon":48},{"type":52,"investigatorFullName":21,"investigatorTitle":21,"investigatorAffiliation":21,"oldNameTitle":21,"oldOrganization":21},"SPONSOR","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":63,"type":64},20,"ESTIMATED","INTERVENTIONAL",[67],"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.",[70,71],"Prostate Cancer (Diagnosis)","Transperineal Cryoablation",[73,74,75],"cryoablation","prostate","Barrigel","NOT_YET_RECRUITING","2026-04-28",{"date":79,"type":80},"2026-05-05","ACTUAL",{"date":82,"type":64},"2026-06-01",{"date":84,"type":64},"2028-06-01",{"name":5,"class":6},1]