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NCT Number: NCT07340710

Decreasing Edema With a Novel OCS Solution 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.

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Key information

Conditions

Lung Transplant

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OCS Lung System

Device

Donor lungs preserved on OCS Lung System

Static cold storage

Other

Donor Lungs preserved on Static Cold Storage

Primary outcomes

  1. 30-day patient and graft survival with freedom from PGD3

    Time frame: 30-days post-transplant

    The primary endpoint is 30-day patient and graft survival with freedom from PGD 3 within the initial 72-hours (T0-T72).

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Church

CONTACT

[email protected]

978-289-3546

Kelly Jork

CONTACT

[email protected]

978-494-3918

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

Decreasing Edema With a Novel OCS Solution (DENOVO) Trial

Acronym: DENOVO

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jan 14, 2026
Registry last updated
Jan 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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