US National TOP Registry
Recruiting
- Conditions
- Lung Transplant
- Interventions
- Device: OCS Lung
- Registration Number
- NCT06513091
- Lead Sponsor
- TransMedics
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10000
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description OCS Lung Transplant Recipients OCS Lung The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry.
- Primary Outcome Measures
Name Time Method One-year patient and graft survival 1-year post-transplant Recipients' one-year patient and graft survival rates
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
St. Joseph's Hospital & Medical Center
🇺🇸Phoenix, Arizona, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
Duke University
🇺🇸Durham, North Carolina, United States
Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States