Lung Diseases
Conditions
Keywords
EVLP, ex vivo lung perfusion, organ perfusion, CLES, centralized lung evaluation system, united therapeutics
Brief summary
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.
Interventions
DEVICECentralized Lung Evaluation System
Assessment of allograft lung for transplant suitability
PROCEDURELung Transplant
Orthotopic single or double lung transplantation.
Sponsors
Lung Bioengineering Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Each patient must meet all of the following criteria to be enrolled in the Study: 1. 18 years of age or older. 2. Male or female. 3. Patient actively awaiting a single or double lung transplant. 4. Patient or patient's representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures. 5. Patient matches with and undergoes a transplant with a donor lung. Patients who meet any of the following criteria will be excluded from the study: 1. Patients listed for same-side lung re-transplantation. 2. Patients listed for multiple organ transplantation including lung and any other organ. 3. Patients listed for live donor lobar lung transplant. 4. Patients positive for human immunodeficiency virus (HIV ) or Burkholderia cenocepacia infection. 5. Patient receives a standard of care (non-EVLP ) lung transplant but does not match to an EVLP subject based on the criteria for control matching. 6. Transplanted with a lung that was perfused using another EVLP technology. 7. Participating in another respiratory or cardiovascular clinical trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 12 Month Survival or Freedom From Mortality | 12 Months | Survival at 12 months following lung transplantation |
Countries
United States
Participant flow
Pre-assignment details
Enrolled subjects were assigned at the time of lung transplantation. Subjects receiving donor lungs after ex vivo lung perfusion (EVLP) using the Centralized Lung Evaluation System (CLES) were assigned to the EVLP Group. Subjects receiving standard of care (non-EVLP) lung transplantation were assigned to the Control Group based on prespecified inclusion/exclusion criteria.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 59.66 Years STANDARD_DEVIATION 10.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 74 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 17 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 131 Participants |
| Sex: Female, Male Female | 32 Participants |
| Sex: Female, Male Male | 48 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 15 / 94 | 6 / 80 |
| other Total, other adverse events | 85 / 94 | 73 / 80 |
| serious Total, serious adverse events | 77 / 94 | 63 / 80 |
Outcome results
None listed