Decreasing Edema With a Novel OCS Solution Trial (NCT07340710) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Decreasing Edema With a Novel OCS Solution Trial
450 participantsStarted 2026-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Donor Inclusion/Exclusion Criteria
Inclusion Criteria:
* 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.
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:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
30-day patient and graft survival with freedom from PGD3