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US National TOP Registry

NCT06513091 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 10000

Last updated 2025-09-03

No results posted yet for this study

Summary

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.

Conditions

  • Lung Transplant

Interventions

DEVICE

OCS Lung

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

Sponsors & Collaborators

  • TransMedics

    lead INDUSTRY

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-23
Primary Completion
2034-11-30
Completion
2039-11-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06513091 on ClinicalTrials.gov