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The Organ Care System (OCS) Lung Thoracic Organ Perfusion (TOP) Post Approval Study (PAS) Registry - OCS Lung TOP PAS Registry

Recruiting

To collect additional real-world safety and effectiveness data for the OCS™ Lung System and to expand the long-term clinical evidence supporting the use of OCS™Lung System in lung transplantation.

I'm interested

All
18 Years and over
This study is NOT accepting healthy volunteers
This is an all-comers registry that will enroll all:
• Consented patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
• Consented 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 the first 289 eligible/PAS consented 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 the first 266 eligible/PAS consented 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.

Device: OCS Lung System

Lung Transplantation

Clinics and Surgery Center (CSC)

Tracy Bui - tbui@umn.edu
Stephen Huddleston
NA
STUDY00003837
NCT03639025
See this study on ClinicalTrials.gov

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