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Not yet recruiting NCT07340710

Decreasing Edema With a Novel OCS Solution Trial

No phase Interventional Lung Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OCS Lung System, Static Cold Storage.
Who it may be relevant to
Registry conditions: Lung Transplant. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Decreasing Edema With a Novel OCS Solution (DENOVO) Trial

Overview

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.

Interventions

  • Device OCS Lung System
    Donor lungs preserved on OCS Lung System
  • Other Static Cold Storage
    Donor Lungs preserved on Static Cold Storage

Primary outcome measures

  • 30-day patient and graft survival with freedom from PGD3 [Time frame: 30-days post-transplant]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07340710 · OCS-LUN-021925

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗