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

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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.


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
We found this trial at
2
sites
Indianapolis, Indiana 46202
Phone: 317-962-9700
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Indianapolis, IN
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462 1st Avenue
New York, New York 10010
Phone: 212-263-7185
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New York, NY
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