OCS Lung SystemNCT04194398
OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
An observational study of OCS Lung System, run by TransMedics at 8 sites in 3 countries.
Trial summary
Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- OCS Lung System
- What is being tested?
- OCS Lung System
- Type of treatment
- Medical device
- How many people
- 79 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 31 Dec 2018to 30 Sep 2021
- 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
- Adult, Older adult
Study population: Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.
Who may be able to join
- Registered male or female primary double lung transplant candidate
- Age ≥18 years old
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Who cannot join
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Duke University Medical Center
Durham, North Carolina, 27710
University of California at Los Angeles
Los Angeles, California, 90095
University of Minnesota
Minneapolis, Minnesota, 55455
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of California at San Francisco
San Francisco, California, 94143
About this study
Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
Read the detailed description
The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.
- Conditions
- OCS Lung System
- Being tested
- OCS Lung System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Lung SystemDevice
Patients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study.
| Study group | Role | What they receive |
|---|---|---|
| OCS Expand Trial Cohort | All patients previously enrolled in the EXPAND Lung trial. Receives: Device: OCS Lung System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient and graft survival
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Measured: 2 years
Patient and graft survival
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Measured: 3 years
Patient and graft survival
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Measured: 4 years
Patient and graft survival
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Measured: 5 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Measured: 2 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Measured: 3 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Measured: 4 years
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2019
- Study start31 Dec 2018
- Primary completion30 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for OCS Lung SystemStudies of the same condition, open and under way.
- More trials run by TransMedicsThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04194398
- Sponsor's protocol ID
- OCS-LUN-122018
- Status last verified
- Feb 2022
- First submitted
- 9 Dec 2019
- Last updated
- 7 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Loor G, Warnecke G, Villavicencio MA, Smith MA, Zhou X, Kukreja J, Ardehali A, Hartwig MG, Daneshmand MA, Hertz MI, Huddleston SJ, Haverich A, Madsen JC, Neyrinck A, Van Raemdonck D. Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantation. EClinicalMedicine. 2025 Jul 8;85:103334. doi: 10.1016/j.eclinm.2025.103334. eCollection 2025 Jul.
PubMed 40686680
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OCS Lung Expand Post-Approval Study - Expand Follow-Up Data Collection
- ClinicalTrials.gov ID
- NCT04194398
- Acronym / sponsor ID
- OCS-LUN-122018
- Conditions
- OCS Lung System
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 11 Dec 2019 (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.
Collection of five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System.
Detailed description
The purpose of this continuation study is to collect five year follow-up data on patients who have already participated in the EXPAND Lung trial and have had transplants with donor lungs preserved on the OCS Lung System. The EXPAND Lung trial results have been presented and have shown positive results in the use of expanded criteria donor lungs and patient follow-up, post-transplant. The current study is being conducted to continue to collect follow-up on participants in the EXPAND study, in order to evaluate long-term patient survival status and BOS diagnosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCS Expand Trial Cohort | – | Device: OCS Lung SystemAll patients previously enrolled in the EXPAND Lung trial. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients previously enrolled in the Expand Lung trial who received lungs preserved on the OCS Lung System.
Key inclusion criteria (3 listed)
- Registered male or female primary double lung transplant candidate
- Age ≥18 years old
- Signed: 1) written informed consent document and 2) authorization to use and disclose protected health information
Key exclusion criteria (3 listed)
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Chronic use of hemodialysis or diagnosis of chronic renal insufficiency
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 |
|---|---|---|
| OCS Lung SystemPatients previously transplanted with lungs preserved on the OCS Lung System in the Expand Lung study. | Device | OCS Expand Trial Cohort |
Primary outcome
Patient and graft survival
Time frame: 2 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Patient and graft survival
Time frame: 3 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Patient and graft survival
Time frame: 4 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Patient and graft survival
Time frame: 5 years
Survival of graft and survival as evaluated at follow-up visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 2 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 3 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 4 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Presence or absence of bronchiolitis obliterans sydrome (BOS)
Time frame: 5 years
Evaluation of BOS as determined by follow-up evaluation visit/call with patient or health care provider.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2022.
- Derived from this study: PubMed 40686680Loor G, Warnecke G, Villavicencio MA, Smith MA, Zhou X, Kukreja J, Ardehali A, Hartwig MG, Daneshmand MA, Hertz MI, Huddleston SJ, Haverich A, Madsen JC, Neyrinck A, Van Raemdonck D. Long-term outcomes of the international EXPAND trial of Organ Care System (OCS) Lung preservation for lung transplantation. EClinicalMedicine. 2025 Jul 8;85:103334. doi: 10.1016/j.eclinm.2025.103334. eCollection 2025 Jul.
- Individual participant dataSharing planned: Undecided
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of OCS Lung System, run by TransMedics at 8 sites in 3 countries.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 7 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Patient and graft survival (time frame: 2 years). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04194398, which also lists 1 linked publication.
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 7 Apr 2022; AzTrials last refreshed its copy on 3 Nov 2026.