[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619733":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":19,"centralContacts":20,"locations":30,"responsibleParty":53,"collaborators":55,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":9,"officialTitle":63,"acronym":64,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":19,"enrollmentInfo":68,"targetDuration":19,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":33,"whyStopped":19,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"iiShield","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Kidney Protective Jacket","EXPERIMENTAL","Application of the KPJ to the renal transplant.",[13],"Device: Kidney Protective Jacket",[15],{"type":16,"name":9,"description":17,"armGroupLabels":18,"otherNames":19},"DEVICE","The KPJ™ is a novel thermal insulating protective jacket specifically designed to be applied to the kidney during transplant anastomoses, or the SWIT interval. It is applied prior to removing the kidney from cold storage, and remains on for the duration of anastomoses, after which it can be easily removed.\n\nThe Kidney Protective Jacket (KPJ) was designed and developed in accordance with ISO 13485 and 21 CFR 820 design control requirements. Throughout the development process, relevant standards were applied, including those related to risk management (ISO 14971), usability engineering (IEC 62366), biocompatibility of materials (ISO 10993 series), and sterilisation validation (ISO 11137).\n\nManufacturing is carried out by an ISO 13485-certified contract manufacturer, with processes including injection moulding of medical-grade silicone, assembly of the sterile barrier system (comprising a medical-grade plastic tray and Tyvek® seal), and final device packaging. Sterilisation is performed us",[9],null,[21,26],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},"Amy Hort, MBBS (HONS), MS, FRACS","CONTACT","+61432782850","amy.hort@health.nsw.gov.au",{"name":27,"role":23,"phone":28,"phoneExt":19,"email":29},"Phoebe Lau, BME (HONS), ME","+61 421 931 429","phoebe@iishield.com",[31],{"facility":32,"status":33,"city":34,"state":35,"zip":36,"country":37,"countryCode":38,"cosmosGeoPoint":39,"geoPoint":44,"contacts":45},"Westmead Hospital","RECRUITING","Westmead","New South Wales","2145","Australia","AU",{"type":40,"coordinates":41},"Point",[42,43],150.98768,-33.80383,{"lat":43,"lon":42},[46,47,51],{"name":22,"role":23,"phone":24,"phoneExt":19,"email":25},{"name":48,"role":23,"phone":49,"phoneExt":19,"email":50},"Ahmer Hameed, MBBS, PHD, FRACS, PFET","+61423843066","ahmer.hameed@sydney.edu.au",{"name":22,"role":52,"phone":19,"phoneExt":19,"email":19},"PRINCIPAL_INVESTIGATOR",{"type":54,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR",[56],{"name":57,"class":58},"Western Sydney Local Health District","OTHER","100619733","kidney-protective-jacket-100619733",false,"NCT07348458","The Effect of Intraoperative Thermal Kidney Insulation on Current Kidney Transplantation Surgical Practices","KPJ","Inclusion Criteria:\n\n* All deceased and living donor kidneys that are deemed suitable for transplantation\n* All suitable recipients who are 18 years or greater, and undergoing their first or second kidney transplant\n* All recipients must be able to provide full informed consent\n\nExclusion Criteria:\n\n* Paediatric donor kidneys (kidneys from donors \\\u003C 16 years in age)\n* Patients with a known allergy or hypersensitivity to silicone","ALL","18 Years",{"count":69,"type":70},20,"ESTIMATED","INTERVENTIONAL",[73],"NA","This is a safety study designed to investigate the safety of utilizing the Kidney Protective Jacket (KPJ)™ during kidney transplantation. In general, we aim to use the device in all possible recipients, aiming to demonstrate its safety in the variable circumstances that may arise during kidney transplantation, e.g. single or multiple renal vessels, different-sized kidneys, and variable recipient size and weight.",[76],"Kidney Transplant",[78,79,80,81,9,82],"Kidney transplant","Renal transplant","Second warm ischaemic time","Ischaemia-reperfusion injury","Graft cooling","2026-03-23",{"date":85,"type":86},"2026-03-25","ACTUAL",{"date":88,"type":86},"2026-03-01",{"date":90,"type":70},"2026-12-31",{"name":5,"class":6},1]