Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation (EVLP XPS)

March 24, 2026 updated by: Hannover Medical School
Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.

Study Overview

Status

Terminated

Study Type

Observational

Enrollment (Actual)

1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Hanover, Germany, 30625
        • Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Listed patients for lung transplantation

Description

Inclusion Criteria:

  • Min Age 18 years
  • Acceptance of the organ using the XPS™ ex vivo lung perfusion system is made by the center based on clinical assessment and visual inspection

Exclusion Criteria:

  • The usual criteria for the assessment of donors apply
  • The transplanting surgeon is not satisfied with the lung assessment on the XPS™ according to clinical criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Survival of patients 1 year after transplantation
Time Frame: 1 year after transplantation
1 year after transplantation

Secondary Outcome Measures

Outcome Measure
Time Frame
Occurrence of primary graft dysfunction (PGD) after transplantation
Time Frame: 0, 24, 48, 72 hours postTx
0, 24, 48, 72 hours postTx

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Fabio Ius, Prof. Dr., Hannover Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2025

Primary Completion (Actual)

March 3, 2026

Study Completion (Actual)

March 3, 2026

Study Registration Dates

First Submitted

January 17, 2025

First Submitted That Met QC Criteria

January 27, 2025

First Posted (Actual)

January 28, 2025

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • EVLP XPS 2023

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Lung Transplantation

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