Clinical Trial

US National TOP Registry

Recruiting
View on ClinicalTrials.gov →
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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-18; most recent amendment 2025-09-02.
Status change: Not Yet Recruiting → Recruiting 2024-10-21
Trial Details
NCT Number NCT06513091
Lead Sponsor TransMedics
Conditions Lung Transplant
Enrollment 10,000 participants
Start Date 2025-01-23
Primary Completion 2034-11 (estimated)
Study Completion 2039-11 (estimated)
Updated on ClinicalTrials.gov 2025-09-03