Print

Purpose

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 12 months or hospital discharge post-transplant.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 cenocepacia 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

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
EVLP
  • Device: Centralized Lung Evaluation System
    Assessment of allograft lung for transplant suitability
  • Procedure: Lung Transplant
    Orthotopic single or double lung transplantation.
Active Comparator
Control
  • Procedure: Lung Transplant
    Orthotopic single or double lung transplantation.

More Details

Status
Completed
Sponsor
Lung Bioengineering Inc.

Study Contact

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.