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Decreasing Edema With a Novel OCS Solution Trial
Sponsor: TransMedics
Summary
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.
Official title: Decreasing Edema With a Novel OCS Solution (DENOVO) Trial
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-03
Completion Date
2028-02
Last Updated
2026-01-14
Healthy Volunteers
No
Conditions
Interventions
OCS Lung System
Donor lungs preserved on OCS Lung System
Static Cold Storage
Donor Lungs preserved on Static Cold Storage