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Recruiting

NCT Number: NCT06513091

US National TOP Registry

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.

Recruiting

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Key information

Conditions

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Joseph's Hospital & Medical Center, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

All lung transplant recipients

Treatment and study plan

OCS Lung

Device

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

Primary outcomes

  1. One-year patient and graft survival

    Time frame: 1-year post-transplant

    Recipients' one-year patient and graft survival rates

Study contacts

Contact information is provided by the study sponsor or research team.

Julia Church

CONTACT

[email protected]

9782893546

Kausar Qidwai

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

TransMedics

Industry

Registry information

Official study title

US National OCS Lung Thoracic Organ Perfusion (TOP) Registry

Important dates

Study start
2025
Primary completion
2034
Study completion
2039
First posted
Jul 22, 2024
Registry last updated
Sep 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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