OCS™ Lung TOP Registry For Donor Lungs for Transplantation

NCT03639025 · tracked via the Priya Life Science USA tracker

Sponsor

TransMedics

Phase

Observational

Started

2018-12-10

Last updated

2025-08-27

Condition(s) studied

Lung Transplantation

Investigational drug(s) / intervention(s)

OCS Lung System

OCS Lung System: The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: * Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. * Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. * Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.

Study summary

Single-arm, prospective, multi-center, post-approval U.S. registry

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

This is an all-comers registry that will enroll all: * Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and * Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and * All donor lungs that were perfused on OCS Lung System. Enrolled patients will fall into one of the following three possible analysis categories: * TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System. * TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System. * All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.

Primary outcome measure(s)

12-month patient and graft survival post double-lung transplant — 12 months
Primary Effectiveness Endpoint

Trial sites (18)

Facility	City	Region
St. Joseph's Hospital and Medical Center	Phoenix	Arizona
UCLA	Los Angeles	California
Stanford University	Palo Alto	California
UCSF	San Francisco	California
Tampa General Hospital	Tampa	Florida
Emory	Atlanta	Georgia
University of Chicago	Chicago	Illinois
Johns Hopkins	Baltimore	Maryland
Massachusetts General Hospital	Boston	Massachusetts
Henry Ford Health System	Detroit	Michigan
University of Minnesota	Minneapolis	Minnesota
Nebraska Medical Center	Omaha	Nebraska
Duke University	Durham	North Carolina
Temple University	Philadelphia	Pennsylvania
Baylor Scott & White Research Institute	Dallas	Texas
Baylor St. Luke's Medical Center	Houston	Texas
Houston Methodist	Houston	Texas
Medical College of Wisconsin	Milwaukee	Wisconsin

More TransMedics trials in the USA

US National OCS Liver Perfusion (OLP) Registry Recruiting

US National TOP Registry Recruiting

OCS Heart Perfusion Post-Approval Registry Active, not recruiting

OCS DCD Heart + CAP Continued Follow-Up Active, not recruiting

OCS Liver Perfusion (OLP) Post-Approval Registry Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03639025 on ClinicalTrials.gov ↗ ← All trials in the USA