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
This trial does not accept healthy volunteersQualifiers
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
Design model
Single group
Treatments tested in this trial
OCS Lung System
DeviceDonor lungs preserved on OCS Lung System
Static Cold Storage
Other interventionDonor Lungs preserved on Static Cold Storage
Treatment groups
450 Participants
are divided into 2 treatment groupsGroup A: OCS LungExperimental treatment 1 intervention
Group B: Static Cold StorageActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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-transplantLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: