Recruiting

Observational Study

Sponsor:

TransMedics

Code:

NCT06513091

Conditions

Lung Transplant

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

OCS Lung

Study Details

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.

Conditions

Lung Transplant

Study ID

NCT06513091

Start date

Jan 23, 2025

Status verified date

Feb, 2025

Completion date

Nov, 2039

Anticipated

Primary completion date

Nov, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

All lung transplant recipients

Study Design

Enrollment

10000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Non-OCS Lung Transplant Recipients

Patients transplanted using other preservation modalities for benchmarking clinical outcomes.

Interventions

OCS Lung

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Julia Church

9782893546jdeane@transmedics.com

Kausar Qidwai

kqidwai@transmedics.com

Locations

St. Joseph's Hospital & Medical Center

Recruiting

Phoenix, Arizona, United States, 85013

Contacts

Brian Mutoff

brian.mutoff@commonspirit.org

Principal Investigator:

Michael Smith, MD

Stanford University School of Medicine

Recruiting

Stanford, California, United States, 94305

Contacts

Tiffany Koyano

650-206-0141tkoyano3@stanford.edu

Principal Investigator:

Anson Lee, MD

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Nicholas Lemke

ntlemke@umn.edu

Principal Investigator:

Stephen Huddleston, MD PhD

Duke University

Recruiting

Durham, North Carolina, United States, 27705

Contacts

Sarah Casalinova

sarah.casalinova@duke.edu

Principal Investigator:

Matthew Hartwig, MD

Baylor Scott & White Research Institute

Recruiting

Dallas, Texas, United States, 75246

Contacts

Erin Lee

214-818-7621Erin.Lee@BSWHealth.org

Principal Investigator:

Gary Schwartz, MD

Baylor College of Medicine

Recruiting

Houston, Texas, United States, 77030

Contacts

Andres Leon Pena, MD

713-798-7533andres.leonpena@bcm.edu

Principal Investigator:

Gabriel Loor, MD

Medical College of Wisconsin

Recruiting

Milwaukee, Wisconsin, United States, 53226

Principal Investigator:

Lucian Durham, MD, PhD

More Information

Sponsor

TransMedics

Last update posted

Sep 3, 2025

Last verified

Feb, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by TransMedics on 2025-09-03.