OCS Lung System EXPAND II Trial
Purpose
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.
Condition
- Lung Transplantation
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 Criteria
- 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- OCS Lung System
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental OCS Preservation |
|
More Details
- Status
- Terminated
- Sponsor
- TransMedics
Study Contact
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 donor); or - Donor age ≥ 55 years old