[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05940857":3,"trial-entities:NCT05940857":346,"trial-summary:NCT05940857":350},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":16,"phases":21,"enrollment_info":22,"interventions":25,"primary_outcomes":32,"secondary_outcomes":37,"sex":38,"minimum_age":16,"maximum_age":16,"healthy_volunteers":14,"eligibility_criteria":39,"std_ages":43,"locations":47,"central_contacts":332,"overall_officials":340,"references":344,"see_also_links":345},"NCT05940857","OCS-LIVER-OLP-II","US National OCS Liver Perfusion (OLP) Registry","RECRUITING","2031-10","2024-08","2024-08-16","2021-10-14","TransMedics","INDUSTRY",false,"This Registry is a sponsor-initiated, multi-center, observational, post-approval registry with an independent academic oversight.\n\nTransMedics has contracted with United Network for Organ Sharing (UNOS) the Federal manager of the U.S. national transplant outcomes registry to obtain data that is routinely collected by the Organ Procurement and Transplantation Network (OPTN) on all transplanted organs in the U.S. for both the OCS liver transplanted patients as well as patients transplanted using other preservation modalities. Additional data will be collected by participating centers using OCS Liver perfusion.",null,[18],"Liver Transplant",[],"OBSERVATIONAL",[],{"count":23,"type":24},100000,"ESTIMATED",[26],{"type":27,"name":28,"description":29,"armGroupLabels":30},"DEVICE","OCS Liver","The TransMedics® Organ Care System (OCS) Liver is an FDA approved portable extracorporeal liver perfusion and monitoring system.",[31],"OCS Liver Transplant Recipients",[33],{"measure":34,"description":35,"timeFrame":36},"Survival","Recipients' patient and graft survival rates will be the primary clinical outcomes measures for all OCS Liver transplanted recipients compared to recipients receiving liver transplants using non-OCS preservation methods (cold static storage or other perfusion devices or a combination of both). This data will be obtained directly from UNOS\u002FOPTN database.","5 years post-transplant",[],"ALL",{"inclusion":40,"exclusion":41,"raw_text":42},[],[],"All liver transplant recipients.",[44,45,46],"CHILD","ADULT","OLDER_ADULT",[48,64,77,90,102,115,128,141,154,166,179,193,206,219,232,244,257,269,282,295,307,319],{"facility":49,"status":7,"city":50,"state":51,"zip":52,"country":53,"contacts":54,"geoPoint":61},"University of Alabama","Birmingham","Alabama","35294","United States",[55,58],{"name":56,"role":57},"Leigh McManus","CONTACT",{"name":59,"role":60},"Robert Cannon, MD","PRINCIPAL_INVESTIGATOR",{"lat":62,"lon":63},33.52066,-86.80249,{"facility":65,"status":7,"city":66,"state":67,"zip":68,"country":53,"contacts":69,"geoPoint":74},"Mayo Clinic Hospital Arizona","Phoenix","Arizona","85054",[70,72],{"name":71,"role":57},"Dakota Hohenwalter",{"name":73,"role":60},"Amit K. Mathur, MD",{"lat":75,"lon":76},33.44838,-112.07404,{"facility":78,"status":7,"city":79,"state":80,"zip":81,"country":53,"contacts":82,"geoPoint":87},"University of California San Diego","La Jolla","California","92037",[83,85],{"name":84,"role":57},"Denya Arellano",{"name":86,"role":60},"Gabriel Schnickel, MD, MPH",{"lat":88,"lon":89},32.84727,-117.2742,{"facility":91,"status":7,"city":92,"state":80,"zip":93,"country":53,"contacts":94,"geoPoint":99},"University of California San Francisco","San Francisco","94143",[95,97],{"name":96,"role":57},"Joanne Kwan",{"name":98,"role":60},"Garrett Roll, MD",{"lat":100,"lon":101},37.77493,-122.41942,{"facility":103,"status":7,"city":104,"state":105,"zip":106,"country":53,"contacts":107,"geoPoint":112},"Mayo Clinic Hospital Florida","Jacksonville","Florida","32224",[108,110],{"name":109,"role":57},"Jessica Toukmehji",{"name":111,"role":60},"Shennen Mao, MD",{"lat":113,"lon":114},30.33218,-81.65565,{"facility":116,"status":7,"city":117,"state":118,"zip":119,"country":53,"contacts":120,"geoPoint":125},"Emory University Hospital","Atlanta","Georgia","30322",[121,123],{"name":122,"role":57},"Jeryl Huckaby",{"name":124,"role":60},"Denise Jennifer Lo, MD",{"lat":126,"lon":127},33.749,-84.38798,{"facility":129,"status":7,"city":130,"state":131,"zip":132,"country":53,"contacts":133,"geoPoint":138},"University of Kentucky Medical Center","Lexington","Kentucky","40536",[134,136],{"name":135,"role":57},"Deepa Valvi",{"name":137,"role":60},"Malay B Shah",{"lat":139,"lon":140},37.98869,-84.47772,{"facility":142,"status":7,"city":143,"state":144,"zip":145,"country":53,"contacts":146,"geoPoint":151},"Beth Israel Deaconess Medical Center","Boston","Massachusetts","02215",[147,149],{"name":148,"role":57},"Madelyn Subocz",{"name":150,"role":60},"David D. Lee, MD",{"lat":152,"lon":153},42.35843,-71.05977,{"facility":155,"status":7,"city":156,"state":144,"zip":157,"country":53,"contacts":158,"geoPoint":163},"Lahey Clinic Medical Center","Burlington","01805",[159,161],{"name":160,"role":57},"Kirsten Peterson",{"name":162,"role":60},"Mohamed E. Akoad, MD",{"lat":164,"lon":165},42.50482,-71.19561,{"facility":167,"status":7,"city":168,"state":169,"zip":170,"country":53,"contacts":171,"geoPoint":176},"University of Michigan Medical Center","Ann Arbor","Michigan","48109",[172,174],{"name":173,"role":57},"Nicholas Demchuk",{"name":175,"role":60},"Seth Waits, MD",{"lat":177,"lon":178},42.27756,-83.74088,{"facility":180,"status":7,"city":181,"state":169,"zip":182,"country":53,"contacts":183,"geoPoint":190},"Henry Ford Hospital","Detroit","48202",[184,186,188],{"name":185,"role":57},"Matthew Callaghan",{"name":187,"role":57},"Iman Francis",{"name":189,"role":60},"Ahmed Nassar, MD",{"lat":191,"lon":192},42.33143,-83.04575,{"facility":194,"status":7,"city":195,"state":196,"zip":197,"country":53,"contacts":198,"geoPoint":203},"Mayo Clinic Hospital Minnesota","Rochester","Minnesota","55905",[199,201],{"name":200,"role":57},"Candy Peterman",{"name":202,"role":60},"Julie K. Heimbach, MD",{"lat":204,"lon":205},44.02163,-92.4699,{"facility":207,"status":7,"city":208,"state":209,"zip":210,"country":53,"contacts":211,"geoPoint":216},"SSM Health Saint Louis University Hospital","St Louis","Missouri","63103",[212,214],{"name":213,"role":57},"Craig Dedert",{"name":215,"role":60},"Henry Randall, MD",{"lat":217,"lon":218},38.62727,-90.19789,{"facility":220,"status":7,"city":221,"state":222,"zip":223,"country":53,"contacts":224,"geoPoint":229},"University of Nebraska Medical Center","Omaha","Nebraska","68198",[225,227],{"name":226,"role":57},"Michelle Leahy",{"name":228,"role":60},"Shaheed Merani, MD, PhD",{"lat":230,"lon":231},41.25626,-95.94043,{"facility":233,"status":7,"city":234,"state":234,"zip":235,"country":53,"contacts":236,"geoPoint":241},"NY Presbyterian Hospital\u002FColumbia Univ. Medical Center","New York","10032",[237,239],{"name":238,"role":57},"Rachel Nuccitelli",{"name":240,"role":60},"Tomoaki Kato, MD",{"lat":242,"lon":243},40.71427,-74.00597,{"facility":245,"status":7,"city":246,"state":247,"zip":248,"country":53,"contacts":249,"geoPoint":254},"Carolinas Medical Center\u002FAtrium Health","Charlotte","North Carolina","28203",[250,252],{"name":251,"role":57},"Katheryn Peterson",{"name":253,"role":60},"Dionisios Vrochides, MD, PhD",{"lat":255,"lon":256},35.22709,-80.84313,{"facility":258,"status":7,"city":259,"state":247,"zip":260,"country":53,"contacts":261,"geoPoint":266},"Duke Medical Center","Durham","27710",[262,264],{"name":263,"role":57},"Jerry Turner",{"name":265,"role":60},"Debra Sudan, MD",{"lat":267,"lon":268},35.99403,-78.89862,{"facility":270,"status":7,"city":271,"state":272,"zip":273,"country":53,"contacts":274,"geoPoint":279},"Thomas Jefferson University Hospital","Philadelphia","Pennsylvania","19107",[275,277],{"name":276,"role":57},"Willa Meyer",{"name":278,"role":60},"Ashesh Shah, MD",{"lat":280,"lon":281},39.95238,-75.16362,{"facility":283,"status":7,"city":284,"state":285,"zip":286,"country":53,"contacts":287,"geoPoint":292},"UT Southwestern Medical Center","Dallas","Texas","75390",[288,290],{"name":289,"role":57},"Morgan Marsh",{"name":291,"role":60},"David Wojciechowski, DO",{"lat":293,"lon":294},32.78306,-96.80667,{"facility":296,"status":7,"city":297,"state":285,"zip":298,"country":53,"contacts":299,"geoPoint":304},"Houston Methodist","Houston","77030",[300,302],{"name":301,"role":57},"Deborah Pokrass",{"name":303,"role":60},"Mark Hobeika, MD",{"lat":305,"lon":306},29.76328,-95.36327,{"facility":308,"status":7,"city":309,"state":285,"zip":310,"country":53,"contacts":311,"geoPoint":316},"University Hospital, University of Texas Health Science Center","San Antonio","78229",[312,314],{"name":313,"role":57},"Jillian Woodworth",{"name":315,"role":60},"Tarunjeet S Klair, MD",{"lat":317,"lon":318},29.42412,-98.49363,{"facility":320,"status":7,"city":321,"state":322,"zip":323,"country":53,"contacts":324,"geoPoint":329},"University of Utah Medical Center","Salt Lake City","Utah","84112",[325,327],{"name":326,"role":57},"Chinedu Nwaduru, MD",{"name":328,"role":60},"Motaz Selim, MD, PhD",{"lat":330,"lon":331},40.76078,-111.89105,[333,337],{"name":334,"role":57,"phone":335,"email":336},"Kelly Jork","978-494-3918","kjork@transmedics.com",{"name":338,"role":57,"email":339},"Kausar Qidwai","kqidwai@transmedics.com",[341],{"name":342,"affiliation":12,"role":343},"Ahmed Elbetanony, MD","STUDY_DIRECTOR",[],[],{"nct_id":4,"conditions":347,"biomarkers":349},[348],"Liver Transplantation",[],{"nct_id":4,"found":351,"summary":352,"prompt_version":361},true,{"design":353,"status":354,"heading":6,"summary":355,"follow_up":356,"word_count":357,"commitments":358,"compensation":359,"drugs_mentioned":360},"This is an observational study, meaning researchers will collect information without giving new treatments. It plans to include 100,000 liver transplant recipients.","completed","This study is a registry collecting information on liver transplant patients. It is looking at how well patients do after receiving a liver that was preserved using the TransMedics® Organ Care System (OCS) Liver, which is an FDA-approved device. The study will compare these patients to those whose livers were preserved using other methods. The main goal is to see how long patients survive after transplant, specifically at 5 years. Anyone who has received a liver transplant can be included in this registry.","Participants will be followed for 5 years after their liver transplant to measure survival.",83,"Not specified in the trial record.","Not stated in the trial record.",[],"v2"]