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ACTIVE NOT RECRUITING
NCT03639025

OCS™ Lung TOP Registry For Donor Lungs for Transplantation

Sponsor: TransMedics

View on ClinicalTrials.gov

Summary

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

Official title: The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

458

Start Date

2018-12-10

Completion Date

2029-11-30

Last Updated

2025-08-27

Healthy Volunteers

No

Interventions

DEVICE

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.

Locations (18)

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

UCLA

Los Angeles, California, United States

Stanford University

Palo Alto, California, United States

UCSF

San Francisco, California, United States

Tampa General Hospital

Tampa, Florida, United States

Emory

Atlanta, Georgia, United States

University of Chicago

Chicago, Illinois, United States

Johns Hopkins

Baltimore, Maryland, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Henry Ford Health System

Detroit, Michigan, United States

University of Minnesota

Minneapolis, Minnesota, United States

Nebraska Medical Center

Omaha, Nebraska, United States

Duke University

Durham, North Carolina, United States

Temple University

Philadelphia, Pennsylvania, United States

Baylor Scott & White Research Institute

Dallas, Texas, United States

Baylor St. Luke's Medical Center

Houston, Texas, United States

Houston Methodist

Houston, Texas, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States