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Clinical Trials in the USA / NCT03639025
Active, not recruiting Observational

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
No
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)

FacilityCityRegionStatus
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

OCS Heart Perfusion Post-Approval Registry Active, not recruiting
Enhancing Heart Allograft Function With the OCS Heart System Trial Recruiting
US National TOP Registry Recruiting
OCS Liver Perfusion (OLP) Post-Approval Registry Active, not recruiting
OCS DCD Heart + CAP Continued Follow-Up 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