An interventional study of OCS Lung System and Static Cold Storage in Lung Transplant, sponsored by TransMedics. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-14.
Sponsored by TransMedics · Not applicable, Interventional, and Treatment
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.
TransMedics is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Donor Inclusion/Exclusion Criteria
Inclusion Criteria:
Exclusion Criteria:
- Severe traumatic donor lung injury with air and/or blood leak (as seen on radiological studies, bronchial examinations or final visual physical assessment in donor's chest or back table).
Recipient Inclusion/Exclusion:
Inclusion Criteria:
Exclusion:
- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.
Device: OCS Lung System
Other: Static Cold Storage
Donor lungs preserved on OCS Lung System
Donor Lungs preserved on Static Cold Storage
30-day patient and graft survival with freedom from PGD3
The primary endpoint is 30-day patient and graft survival with freedom from PGD 3 within the initial 72-hours (T0-T72).
Time frame: 30-days post-transplant
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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TransMedics