[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"TransMedics\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":125},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,40,64,85,105],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":4},"100619137","decreasing-edema-with-a-novel-ocs-solution-trial-100619137",false,"NCT07340710","Decreasing Edema With a Novel OCS Solution Trial","Decreasing Edema With a Novel OCS Solution (DENOVO) Trial","DENOVO","Donor Inclusion\u002FExclusion Criteria\n\nInclusion Criteria:\n\n* Donor lungs are deemed clinically acceptable for transplantation after physical examination of the donor lungs in the donor and\u002For on the back table in the donor operating room.\n* Eligible for randomization to OCS or SCS treatment arms.\n\nExclusion Criteria:\n\n\\- Severe traumatic donor lung injury with air and\u002For blood leak (as seen on radiological studies, bronchial examinations or final visual physical assessment in donor's chest or back table).\n\nRecipient Inclusion\u002FExclusion:\n\nInclusion Criteria:\n\n* Signed informed consent document and authorization to use and disclose protected health information\n* Double lung transplant candidate\n* Age ≥ 18 years old\n\nExclusion:\n\n\\- Participant in any other interventional clinical or investigational trials\u002Fprograms that may confound the outcomes of this trial.","ALL","18 Years",{"count":20,"type":21},450,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a prospective, multicenter randomized trial of lung transplant recipients transplanted with either a DBD or DCD donor lungs. The DENOVO Trial will enroll a total of 300 patients in the OCS arm and 150 patients in the SCS arm. The primary endpoint will be patient \\& graft survival and freedom of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation.",[27],"Lung Transplant","NOT_YET_RECRUITING","2026-01-13",{"date":31,"type":32},"2026-01-14","ACTUAL",{"date":34,"type":21},"2026-03",{"date":36,"type":21},"2028-02",{"name":38,"class":39},"TransMedics","INDUSTRY",{"id":41,"slug":42,"hasResults":11,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":46,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":48,"targetDuration":4,"studyType":22,"phases":50,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":55,"lastUpdatePostDateStruct":56,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100604130","enhancing-heart-allograft-function-with-the-ocs-heart-system-trial-100604130","NCT07145515","Enhancing Heart Allograft Function With the OCS Heart System Trial","Enhancing Heart Allograft Function With the OCS Heart System (ENHANCE) Trial","ENHANCE","Part A - DCD Donor Hearts \\& DBD Donor Hearts Initially Deemed Unsuitable for Cold Storage (Current Approved Indications):\n\nDonor Inclusion Criteria\n\n* Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and\u002For on the back table in the donor operating room.\n* All DCD donors eligible for functional warm ischemic time criteria ≤ 30 minutes. WIT defined as time from when mean systolic blood pressure (SBP) is \\\u003C50mmHg (sustained for at least 5 minutes) to aortic cross clamp and administration of old cardioplegia in the donor.\n* DBD donor hearts with an expected cross clamp of ≥ 4 hours\n* DBD donor hearts with any of the following organ quality concerns, regardless of cross clamp time:\n\n  * Donor age ≥ 40 years old\n  * Unknown downtime\n  * Insignificant CAD\n  * LVEF ≤ 50%\n\nDonor Exclusion • Moderate to severe aortic incompetence\n\nPart B - DBD Donor Hearts Currently Used with Cold Storage (New Indication):\n\nDonor Inclusion Criteria\n\n* Donor hearts are deemed clinically acceptable for transplantation after physical examination of the donor hearts in the donor chest and\u002For on the back table in the donor operating room.\n* Eligible for randomization to OCS or SCS treatment arms.\n* DBD donor hearts with an expected cross clamp time of \\\u003C 4 hours.\n\nDonor Exclusion\n\n* Moderate to severe aortic incompetence\n* DBD donor with any of the following organ quality concerns:\n\n  * Donor age ≥ 40 years old\n  * Unknown downtime\n  * Insignificant CAD\n  * LVEF ≤ 50%\n\nRecipient Eligibility Criteria (for Part A and B Cohorts)\n\nInclusion\n\n* Signed informed consent document and authorization to use and disclose protected health information\n* Heart transplant candidate\n* Age ≥ 18 years old\n\nExclusion\n\n• Participant in any other interventional clinical or investigational trials\u002Fprograms that may confound the outcomes of this trial",{"count":49,"type":21},655,[24],"This trial is designed to evaluate the safety and effectiveness of the novel OCS Solution and OCS Functional Enhancer (OFE) to support FDA approval in both DBD and DCD heart transplantation. In addition, this trial will evaluate the performance of the novel OCS Solution and OFE compared to Static Cold Storage (SCS) in DBD heart transplantation to potentially demonstrate superiority.",[53],"Heart Transplant","RECRUITING","2026-01-08",{"date":57,"type":32},"2026-01-12",{"date":59,"type":21},"2026-01",{"date":61,"type":21},"2027-07-30",{"name":38,"class":39},8,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":68,"acronym":4,"eligibilityCriteria":69,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":70,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":74,"conditions":75,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},"100509582","us-national-ocs-heart-perfusion-ohp-registry-100509582","NCT05915299","US National OCS Heart Perfusion (OHP) Registry","Inclusion Criteria:\n\n* N\u002FA\n\nExclusion Criteria:\n\n* N\u002FA",{"count":71,"type":21},100000,"5 Years","OBSERVATIONAL","This Registry is a sponsor initiated, multi-center, observational post-approval registry with independent academic oversight.",[53],"2025-10-29",{"date":78,"type":32},"2025-10-30",{"date":80,"type":32},"2023-08-25",{"date":82,"type":21},"2033-08-31",{"name":38,"class":39},37,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":92,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":94,"conditions":95,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":96,"lastUpdatePostDateStruct":97,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},"100555515","us-national-top-registry-100555515","NCT06513091","US National TOP Registry","US National OCS Lung Thoracic Organ Perfusion (TOP) Registry","All lung transplant recipients",{"count":93,"type":21},10000,"The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.",[27],"2025-09-02",{"date":98,"type":32},"2025-09-03",{"date":100,"type":32},"2025-01-23",{"date":102,"type":21},"2039-11",{"name":38,"class":39},7,{"id":106,"slug":107,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":109,"acronym":110,"eligibilityCriteria":111,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":112,"targetDuration":72,"studyType":73,"phases":4,"briefSummary":113,"conditions":114,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":116,"lastUpdatePostDateStruct":117,"startDateStruct":119,"completionDateStruct":121,"leadSponsor":123,"locationsCount":124},"100511547","us-national-ocs-liver-perfusion-olp-registry-100511547","NCT05940857","US National OCS Liver Perfusion (OLP) Registry","National OLP","All liver transplant recipients.",{"count":71,"type":21},"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.",[115],"Liver Transplant","2024-08-13",{"date":118,"type":32},"2024-08-16",{"date":120,"type":32},"2021-10-14",{"date":122,"type":21},"2031-10",{"name":38,"class":39},22,""]