US National TOP Registry
ConditionLung Transplant
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorTransMedics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.
Trial design
Design model
Other
Time perspective
Other
Treatments tested in this trial
OCS Lung
DeviceThe TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.
Treatment groups
10,000 Participants
are divided into 2 treatment groupsGroup A: OCS Lung Transplant Recipients1 intervention
Group B: Non-OCS Lung Transplant Recipients0 interventions
Trial outcomes
Primary outcomes
1
One-year patient and graft survival
Recipients' one-year patient and graft survival rates
Time frame
1-year post-transplantSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov