US National TOP Registry

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
TransMedics
Study ID
NCT06513091
Status
Recruiting
Apply to this trial

Conditions

  • Lung Transplant

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 23, 2025
Status verified
Feb 2025
Primary completion
Nov 30, 2034
Completion
Nov 30, 2039

Study Design

Enrollment
10,000 participants (estimated)

Arms

  • Arm: OCS Lung Transplant Recipients
    The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry.
  • Arm: Non-OCS Lung Transplant Recipients
    Patients transplanted using other preservation modalities for benchmarking clinical outcomes.

Primary Outcome Measure

One-year patient and graft survival [ Time Frame: 1-year post-transplant ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital & Medical CenterPhoenixArizona85013
Brian Mutoff
[email protected]
Michael Smith, MD (PRINCIPAL_INVESTIGATOR)
Stanford University School of MedicineStanfordCalifornia94305
Tiffany Koyano
[email protected]
650-206-0141
Anson Lee, MD (PRINCIPAL_INVESTIGATOR)
University of MinnesotaMinneapolisMinnesota55455
Nicholas Lemke
[email protected]
Stephen Huddleston, MD PhD (PRINCIPAL_INVESTIGATOR)
Duke UniversityDurhamNorth Carolina27705
Sarah Casalinova
[email protected]
Matthew Hartwig, MD (PRINCIPAL_INVESTIGATOR)
Baylor Scott & White Research InstituteDallasTexas75246
Erin Lee
[email protected]
214-818-7621
Gary Schwartz, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of MedicineHoustonTexas77030
Andres Leon Pena, MD
[email protected]
713-798-7533
Gabriel Loor, MD (PRINCIPAL_INVESTIGATOR)
Medical College of WisconsinMilwaukeeWisconsin53226
Kelly Potzner
Lucian Durham, MD, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
St. Joseph's Hospital & Medical Center· Phoenix, AZStanford University School of Medicine· Stanford, CAUniversity of Minnesota· Minneapolis, MNDuke University· Durham, NCBaylor Scott & White Research Institute· Dallas, TXBaylor College of Medicine· Houston, TX

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