- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06795516
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
Conditions
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
-
-
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Hanover, Germany, 30625
- Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
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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.
Sponsor
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
Keywords
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.
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