Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility
| Status: | Recruiting |
|---|---|
| Conditions: | Pulmonary |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/1/2019 |
| Start Date: | January 15, 2019 |
| End Date: | June 1, 2021 |
The objective of this study is to evaluate the safety and effectiveness of the 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 6 months or hospital discharge
post-transplant.
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 6 months or hospital discharge
post-transplant.
Inclusion Criteria:
- Male or female;
- Aged 18 years or older;
- Informed consent is given for participation in the Study by the patient or patient's
designated representative; and
- Patient undergoes lung transplantation.
Exclusion Criteria:
- Patients listed for same-side lung re-transplantation.
- Patients listed for multiple organ transplantation including lung and any other organ.
- Patients listed for live donor lobar lung transplant.
- Patients positive for human immunodeficiency virus (HIV) or Burkholderia cepacia
infection.
- 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.
- Participating in another interventional trial
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