Status:
TERMINATED
OCS Lung System EXPAND II Trial
Lead Sponsor:
TransMedics
Conditions:
Lung Transplantation
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 transplanta...
Detailed Description
Inclusion At least one of the following: * Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or * Expected cross-clamp time \> 6 hours for the second lung; or * Donor after Cardiac Death (DCD don...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 12 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT03343535
Start Date
March 12 2018
End Date
July 6 2022
Last Update
February 28 2024
Active Locations (14)
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1
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, United States, 85013
2
UCLA Medical Center
Los Angeles, California, United States, 90095
3
University of California, San Francisco
San Francisco, California, United States, 94143
4
Stanford University Medical Center
Stanford, California, United States, 94305