Lung TransplantNCT05101460
An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
An observational study of Lung Transplant, run by XVIVO Perfusion at 1 site in United States.
Trial summary
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplant
- What is being tested?
- XVIVO Perfusion System (XPS™) with STEEN Solution™
- Type of treatment
- Medical device
- How many people
- 315 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Oct 2019to 24 Apr 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate
This is an "All Comers Registry" hence will include all patients receiving EVLP lungs.
Trial locations and contacts
1 site in 1 country.
About this study
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
Read the detailed description
The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.
The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.
OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:
- Collects if hospitalized since last follow-up (yes, no), not the number of hospitalizations
- Collects acute rejection episodes (yes treated, yes not treated, no), not the number of episodes
- Collects Karnofsky Score as replacement for Physical and functional capacity
- Employment limitations has been updated to working for income (yes or no)
- No longer collects BOS, XVIVO to request BOS evaluations on subjects with visits prior to June 30, 2020 and any other omissions of end points not available in the data requested via STAR request.
- Collects FEV1 (L) effective June 30, 2020 to calculate CLAD and diagnosis of CLAD, if applicable.
- No longer provides Other, Specify text in STAR request.
- Conditions
- Lung Transplant
- Being tested
- XVIVO Perfusion System (XPS™) with STEEN Solution™
- Keywords
- Lung Transplant; Transplantation lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XVIVO Perfusion System (XPS™) with STEEN Solution™Device
XVIVO Perfusion System (XPS™) with STEEN Solution™
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival at 1 year post-transplant
Primary effectiveness endpoint
Measured: 12 months
Primary Graft Dysfunction (PGD)
Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours
Measured: 72 hours
Secondary outcomes (7)
Post-transplant survival
Survival at 2, 3, 4 and 5 years post-transplant
Measured: 2 years, 3 years, 4 years and 5 years post-transplant
Pulmonary Function Test (FEV1)
Pulmonary Function Test (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is the key lung function test in diagnosing BOS. FEV1 test at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant.
Measured: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)
Rate of Grade 0 through 3 Bronchiolitis Obliterans Syndrome (BOS) at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Clinically, BOS is associated with a progressive decline in forced expiratory volume in one second (FEV1) greater than or equal to 20% of baseline. Decline in FEV1 % increases the risk of development of BOS (Grade 0 to 3).
CLAD is defined as a substantial and persistent decline (≥ 20%) in measured FEV1 value from the reference (baseline) value after lung transplantation, with or without a change in FVC. If CLAD is identified, staging and phenotype will be assigned.
Measured: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Hospitalizations
The presence of in-patient hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
Measured: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Acute Rejection Episodes
The presence of biopsy proven hospital admissions between transplant and 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
Measured: 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
Karnofsky Performance Status Scale (KPS)/Karnofsky score
Karnofsky Performance Status Scale is an assessment tool for functional impairment. It is used to improve understanding of patient needs, ability to carry out daily activities and to assess patient prognosis. Karnofsky score is calculated at 1 year, 2 years, 3 years, 4 years and 5 years post-transplant. Higher the Karnofsky score, better the ability to carry out daily activities.
Measured: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Safety Endpoint
XPS related SAEs from transplant to 30 days post-transplant or initial hospital stay, whichever is longer
Measured: 30 days post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2021
- Study start29 Oct 2019
- Primary completion24 Apr 2029 (estimated)
- Study completion24 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung TransplantStudies 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
- 315 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- XVIVO Perfusion
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sarah Lowe, Study director, XVIVO Perfusion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05101460
- Sponsor's protocol ID
- XVO-003
- Status last verified
- Apr 2025
- First submitted
- 5 Oct 2021
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An All Comers Registry For Normothermic Ex Vivo Lung Perfusion (EVLP) as Assessment of Donor Lungs for Transplant
- ClinicalTrials.gov ID
- NCT05101460
- Acronym / sponsor ID
- XVO-003
- Conditions
- Lung Transplant
- Keywords
- Lung Transplant; Transplantation lung
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 315 participants (estimated)
- Lead sponsor
- XVIVO PerfusionIndustry (pharma, biotech, devices)
- Study start
- 29 Oct 2019 (actual)
- Primary completion
- 24 Apr 2029 (estimated)
- Study completion
- 24 Apr 2029 (estimated)
- First posted
- 1 Nov 2021 (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.
The XVIVO Registry is to collect standard of care clinical data from "all-comers" who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device, and monitor device-related serious adverse events. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
Detailed description
The XVIVO registry is an ongoing, observational, multicenter, retrospective review of patients exposed to XPS™ EVLP-treated lungs. The Registry study is aligned and managed by the UNOS and OPTN data collection process. This registry uses quarterly STAR file data requests for the OPTN data managed by UNOS.
The EVLP procedure and transplantation will be performed per XPS™ Instructions for Use and the treating physician's discretion. Post-transplant clinical care will follow the institution's standard-of-care policies.
OPTN updated the data collected since the submission of the protocol therefore the data collection has changed. The following data has updated collection:
- Collects if hospitalized since last follow-up (yes, no), not the number of hospitalizations
- Collects acute rejection episodes (yes treated, yes not treated, no), not the number of episodes
- Collects Karnofsky Score as replacement for Physical and functional capacity
- Employment limitations has been updated to working for income (yes or no)
- No longer collects BOS, XVIVO to request BOS evaluations on subjects with visits prior to June 30, 2020 and any other omissions of end points not available in the data requested via STAR request.
- Collects FEV1 (L) effective June 30, 2020 to calculate CLAD and diagnosis of CLAD, if applicable.
- No longer provides Other, Specify text in STAR request.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is an "All Comers Registry" hence, no specific investigator sites. All patients receiving EVLP lungs treated with XPS™ will be included in the registry without eligibility criteria or pre-selection. Since the registry collects only standard-of-care data and requires no additional procedures or risks to the subject, a waiver of consent is appropriate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XVIVO Perfusion System (XPS™) with STEEN Solution™XVIVO Perfusion System (XPS™) with STEEN Solution™ | Device | – |
Primary outcome
Survival at 1 year post-transplant
Time frame: 12 months
Primary effectiveness endpoint
Primary Graft Dysfunction (PGD)
Time frame: 72 hours
Rate of Grade 3 Primary Graft Dysfunction (PGD) at 72 hours
7 secondary outcomes
Post-transplant survival
Time frame: 2 years, 3 years, 4 years and 5 years post-transplant
Pulmonary Function Test (FEV1)
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Incidence of Bronchiolitis Obliterans Syndrome (BOS) or Chronic Lung Allograft Dysfunction (CLAD)
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Hospitalizations
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Acute Rejection Episodes
Time frame: 1 year, 1-2 years, 2-3 years, 3-4 years, and 4-5 years post-transplant
Karnofsky Performance Status Scale (KPS)/Karnofsky score
Time frame: 1 year, 2 years, 3 years, 4 years and 5 years post-transplant
Safety Endpoint
Time frame: 30 days post-transplant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Sarah Lowe study director
XVIVO Perfusion
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 Transplant, run by XVIVO Perfusion at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: under way, not looking for participants, as of the sponsor's last update on 21 Apr 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
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 at 1 year post-transplant (time frame: 12 months). The study lists 2 primary outcomes in all. 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 21 Apr 2026.