Decreasing Edema With a Novel OCS Solution Trial (DENOVO)

Decreasing Edema With a Novel OCS Solution (DENOVO) 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lung Transplant
• Intervention / Treatment: Device: OCS Lung System; Other: Static Cold Storage

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kelly Jork; Phone Number: 978-494-3918; Email: kjork@transmedics.com
• Study Contact Backup: Name: Julia Church; Phone Number: 978-289-3546; Email: jdeane@transmedics.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: OCS Lung	Device: OCS Lung System; Donor lungs preserved on OCS Lung System
Active Comparator: Static Cold Storage	Other: Static Cold Storage; Donor Lungs preserved on Static Cold Storage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	30-days post-transplant

Collaborators and Investigators

• Sponsor: TransMedics

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): February 1, 2028

Study Registration Dates

• First Submitted: September 10, 2025
• First Submitted That Met QC Criteria: January 13, 2026
• First Posted (Actual): January 14, 2026

Study Record Updates

• Last Update Posted (Actual): January 14, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OCS-LUN-021925

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes