A Study to Evaluate Increasing Lung Transplant Availability Using Normothermic Ex Vivo Lung Perfusion (EVLP) at a Dedicated EVLP Facility

Overview

About this study

The purpose 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 6 months or hospital discharge post-transplant.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

18 years of age or older.
Male or female.
Patient actively awaiting a single or bilateral lung transplant.
Patient or patient’s representative provides informed consent for participation in the study prior to participating in any study-related assessments or procedures.
Patient matches with and undergoes a transplant with a donor lung.

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.
Participating in another interventional trial.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Tathagat Narula, M.B.B.S., M.D.	Closed for enrollment	Contact information: Michel Tamayo Perez TamayoPerez.Michel@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Tathagat Narula, M.B.B.S., M.D.

Closed for enrollment

Contact information:

Michel Tamayo Perez

TamayoPerez.Michel@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials