Decreasing Edema With a Novel OCS Solution Trial

Starting soon · Not applicable

Conditions studied: Lung Transplant

In brief

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.

Key facts

Study ID

NCT07340710

Run by

TransMedics

People needed

450

Starts

2026-03-01

Expected to finish

2028-02-01

Last updated by the study team

2026-01-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Donor lungs are deemed clinically acceptable for transplantation after physical examination of the donor lungs in the donor and/or on the back table in the donor operating room.
• Eligible for randomization to OCS or SCS treatment arms.

You may not qualify if…

• 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:
• Signed informed consent document and authorization to use and disclose protected health information
• Double lung transplant candidate
• Age ≥ 18 years old
• Exclusion:
• Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.

Full record on ClinicalTrials.gov

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