Decreasing Edema With a Novel OCS Solution Trial
ConditionLung Transplant
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorTransMedics
About this trial
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.
Eligibility criteria
Qualifiers
None
Disqualifiers
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.
Signed informed consent document and authorization to use and disclose protected health information
Double lung transplant candidate
Trial design
Treatments tested in this trial
- OCS Lung System
- Static Cold Storage
Treatment groups
450 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov