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

Lung Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641677
• Other study ID #: EVP-DEV-LTX-301
• Status: Completed
• Phase: N/A
• Start date: January 15, 2019
• Est. completion date: January 18, 2024

Study information

• Verified date: January 2024
• Source: Lung Bioengineering Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: January 18, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Diseases

Intervention

Device:
• Centralized Lung Evaluation System
Assessment of allograft lung for transplant suitability

Procedure:
• Lung Transplant
Orthotopic single or double lung transplantation.

Locations

Country	Name	City	State
United States	University of Michigan Medical Center	Ann Arbor	Michigan
United States	Emory University Hospital	Atlanta	Georgia
United States	Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Maryland Medical System	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Duke University Medical Center	Durham	North Carolina
United States	INOVA Fairfax Hospital	Falls Church	Virginia
United States	Spectrum Health	Grand Rapids	Michigan
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	Vanderbilt University	Nashville	Tennessee
United States	NYU Langone Health	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Lung Bioengineering Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	12 month survival		12 months