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The objective of this study is to evaluate the safety and effectiveness of the Centralized Lung Evaluation System (CLES) in enabling evaluation of potential donor lungs not otherwise used for transplant into subjects with end stage, survival-limiting lung disease in need of lung transplantation. This will be accomplished by evaluating subject survival at the later of 12 months or hospital discharge post-transplant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EVLP | Experimental |
| |
| Control | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Centralized Lung Evaluation System | Device | Assessment of allograft lung for transplant suitability |
|
| Measure | Description | Time Frame |
|---|---|---|
| 12 month survival | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States | ||
| Emory University Hospital |
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| Lung Transplant | Procedure | Orthotopic single or double lung transplantation. |
|
| Atlanta |
| Georgia |
| 30322 |
| United States |
| University of Maryland Medical System | Baltimore | Maryland | 21201 | United States |
| Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| University of Michigan Medical Center | Ann Arbor | Michigan | 48109 | United States |
| Spectrum Health | Grand Rapids | Michigan | 49503 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| NYU Langone Health | New York | New York | 10016 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Cleveland Clinic | Cleveland | Ohio | 44195 | United States |
| Vanderbilt University | Nashville | Tennessee | 37204 | United States |
| INOVA Fairfax Hospital | Falls Church | Virginia | 22042 | United States |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D016040 | Lung Transplantation |
| ID | Term |
|---|---|
| D013510 | Pulmonary Surgical Procedures |
| D019616 | Thoracic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D016377 | Organ Transplantation |
| D014180 | Transplantation |
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