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NOT YET RECRUITING
NCT07340710
NA

Decreasing Edema With a Novel OCS Solution Trial

Sponsor: TransMedics

View on ClinicalTrials.gov

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.

Official title: Decreasing Edema With a Novel OCS Solution (DENOVO) Trial

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2026-03

Completion Date

2028-02

Last Updated

2026-01-14

Healthy Volunteers

No

Conditions

Interventions

DEVICE

OCS Lung System

Donor lungs preserved on OCS Lung System

OTHER

Static Cold Storage

Donor Lungs preserved on Static Cold Storage