Lung TransplantationEVLP XPSNCT06795516
Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation
An observational study of Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
Trial summary
Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- How many people
- 1 participants
- Where
- 1 siteGermany
- Study dates
- 1 Mar 2025to 3 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Listed patients for lung transplantation
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Hannover Medical School, Department of Cardiothoracic, Transplant and Vascular Surgery
Hanover, 30625
About this study
Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.
- Conditions
- Lung Transplantation
- Keywords
- Ex-vivo Perfusion
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival of patients 1 year after transplantation
Measured: 1 year after transplantation
Secondary outcomes (1)
Occurrence of primary graft dysfunction (PGD) after transplantation
Measured: 0, 24, 48, 72 hours postTx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start1 Mar 2025
- Primary completion3 Mar 2026
- Study completion3 Mar 2026
Why it stopped: funding freeze
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fabio Ius, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06795516
- Sponsor's protocol ID
- EVLP XPS 2023
- Acronym
- EVLP XPS
- Status last verified
- Mar 2026
- First submitted
- 17 Jan 2025
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study on the Clinical Use of ex Vivo Lung Perfusion (XPS™) for Lung Transplantation
- ClinicalTrials.gov ID
- NCT06795516
- Acronym / sponsor ID
- EVLP XPS / EVLP XPS 2023
- Conditions
- Lung Transplantation
- Keywords
- Ex-vivo Perfusion
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: funding freeze
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- 1 Mar 2025 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 3 Mar 2026 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Clinical use of ex-vivo perfusion for lung transplantation. Collection, storage and processing of patient data for outcome analysis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Listed patients for lung transplantation
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Survival of patients 1 year after transplantation
Time frame: 1 year after transplantation
1 secondary outcome
Occurrence of primary graft dysfunction (PGD) after transplantation
Time frame: 0, 24, 48, 72 hours postTx
Results and safety
The study was stopped early (reason given: funding freeze). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fabio Ius, Prof. Dr. principal investigator
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Transplantation, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: funding freeze). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival of patients 1 year after transplantation (time frame: 1 year after transplantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.