[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100619137":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":11,"responsibleParty":39,"collaborators":11,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":43,"sex":49,"minAge":50,"maxAge":11,"enrollmentInfo":51,"targetDuration":11,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":11,"overallStatus":60,"whyStopped":11,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":11},{"fullName":5,"class":6},"TransMedics","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"OCS Lung","EXPERIMENTAL",null,[13],"Device: OCS Lung System",{"label":15,"type":16,"description":11,"interventionNames":17},"Static Cold Storage","ACTIVE_COMPARATOR",[18],"Other: Static Cold Storage",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","OCS Lung System","Donor lungs preserved on OCS Lung System",[9],{"type":26,"name":15,"description":27,"armGroupLabels":28,"otherNames":11},"OTHER","Donor Lungs preserved on Static Cold Storage",[15],[30,35],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Julia Church","CONTACT","978-289-3546","jdeane@transmedics.com",{"name":36,"role":32,"phone":37,"phoneExt":11,"email":38},"Kelly Jork","978-494-3918","kjork@transmedics.com",{"type":40,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":52,"type":53},450,"ESTIMATED","INTERVENTIONAL",[56],"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.",[59],"Lung Transplant","NOT_YET_RECRUITING","2026-01-13",{"date":63,"type":64},"2026-01-14","ACTUAL",{"date":66,"type":53},"2026-03",{"date":68,"type":53},"2028-02",{"name":5,"class":6}]