NCT07340710

Brief 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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
450

participants targeted

Target at P75+ for not_applicable

Timeline
21mo left

Started Mar 2026

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress10%
Mar 2026Feb 2028

First Submitted

Initial submission to the registry

September 10, 2025

Completed
4 months until next milestone

First Posted

Study publicly available on registry

January 14, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2026

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

January 14, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

September 10, 2025

Last Update Submit

January 13, 2026

Conditions

Lung Transplant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

OCS Lung

EXPERIMENTAL
Device: OCS Lung System

Static Cold Storage

ACTIVE COMPARATOR
Other: Static Cold Storage

Interventions

Static Cold StorageOTHER

Donor Lungs preserved on Static Cold Storage

Static Cold Storage
OCS Lung SystemDEVICE

Donor lungs preserved on OCS Lung System

OCS Lung

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.
  • \- 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).
  • Signed informed consent document and authorization to use and disclose protected health information
  • Double lung transplant candidate
  • Age ≥ 18 years old
  • \- Participant in any other interventional clinical or investigational trials/programs that may confound the outcomes of this trial.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Julia Church

CONTACT

978-289-3546jdeane@transmedics.com

Kelly Jork

CONTACT

978-494-3918kjork@transmedics.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 10, 2025

First Posted

January 14, 2026

Study Start

March 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

February 1, 2028

Last Updated

January 14, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share