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Recruiting NCT06513091

US National TOP Registry

Observational Lung Transplant

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: OCS Lung.
Who it may be relevant to
Registry conditions: Lung Transplant. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

US National OCS Lung Thoracic Organ Perfusion (TOP) Registry

Overview

The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.

Interventions

  • Device OCS Lung
    The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.

Primary outcome measures

  • One-year patient and graft survival [Time frame: 1-year post-transplant]

Eligibility criteria

All lung transplant recipients

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

United States · 7 centers
  • St. Joseph's Hospital & Medical Center — Phoenix
  • Stanford University School of Medicine — Stanford
  • University of Minnesota — Minneapolis
  • Duke University — Durham
  • Baylor Scott & White Research Institute — Dallas
  • Baylor College of Medicine — Houston
  • Medical College of Wisconsin — Milwaukee

Identifiers

NCT: NCT06513091 · OCS-LUN-TOP-II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗