Decreasing Edema With a Novel OCS Solution Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-31

Study Completion Date

2028-02-29

Brief Summary

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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.

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Detailed Description

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Conditions

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Lung Transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OCS Lung

Group Type EXPERIMENTAL

OCS Lung System

Intervention Type DEVICE

Donor lungs preserved on OCS Lung System

Static Cold Storage

Group Type ACTIVE_COMPARATOR

Static Cold Storage

Intervention Type OTHER

Donor Lungs preserved on Static Cold Storage

Interventions

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OCS Lung System

Donor lungs preserved on OCS Lung System

Intervention Type DEVICE

Static Cold Storage

Donor Lungs preserved on Static Cold Storage

Intervention Type OTHER

Eligibility Criteria

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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.

* 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.

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:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No