OCS Lung System EXPAND II Trial

Stopped early · Not applicable

Conditions studied: Lung Transplantation

In brief

To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.

Key facts

Study ID

NCT03343535

Run by

TransMedics

People needed

46

Starts

2018-03-12

Expected to finish

2022-07-06

Last updated by the study team

2024-02-28

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female primary double lung transplant candidate
• Age ≥ 18 years old
• Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information

You may not qualify if…

• Prior solid organ or bone marrow transplant
• Single lung recipient
• Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
• Participant in any other clinical or investigational trials/programs

Where it is running

• St. Joseph's Hospital and Medical Center — Phoenix, Arizona, United States
• UCLA Medical Center — Los Angeles, California, United States
• University of California, San Francisco — San Francisco, California, United States
• Stanford University Medical Center — Stanford, California, United States
• The Johns Hopkins Hospital — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• University of Minnesota — Minneapolis, Minnesota, United States
• University of Nebraska — Omaha, Nebraska, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Temple University Hospital — Philadelphia, Pennsylvania, United States
• Baylor St. Luke's Medical Center — Houston, Texas, United States
• Houston Methodist — Houston, Texas, United States
• University of Virginia — Charlottesville, Virginia, United States
• Medical College of Wisconsin — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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