Lung TransplantationTOPNCT03639025
OCS™ Lung TOP Registry For Donor Lungs for Transplantation
An observational study of Lung Transplantation, run by TransMedics at 18 sites in United States.
Trial summary
Single-arm, prospective, multi-center, post-approval U.S. registry Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- OCS Lung System
- Type of treatment
- Medical device
- How many people
- 458 participants
- Where
- 18 sitesUnited States
- Study dates
- 10 Dec 2018to 30 Nov 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: All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System
This is an all-comers registry that will enroll all:
- Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Emory
Atlanta, Georgia, 30322
Johns Hopkins
Baltimore, Maryland, 21218
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Chicago
Chicago, Illinois, 60637
Baylor Scott & White Research Institute
Dallas, Texas, 75204
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27710
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
UCLA
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
Nebraska Medical Center
Omaha, Nebraska, 68198
Stanford University
Palo Alto, California, 94304
Temple University
Philadelphia, Pennsylvania, 19140
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
UCSF
San Francisco, California, 94143
Tampa General Hospital
Tampa, Florida, 33606
About this study
Official title: The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
Single-arm, prospective, multi-center, post-approval U.S. registry
Read the detailed description
This is an all-comers registry that will enroll:
- Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.
- Conditions
- Lung Transplantation
- 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
The OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions:
- Reducing ischemic injury through the use of warm, oxygenated blood based perfusion.
- Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients.
- Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant.
| Study group | Role | What they receive |
|---|---|---|
| Standard Donor Lungs Primary Analysis Population | Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. Receives: Device: OCS Lung System | |
| Donor Lungs Initially Unacceptable Primary Analysis Pop. | Recipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. Receives: Device: OCS Lung System | |
| All Other Enrolled Patients | All OCS Lung transplanted patients that do not meet any of the above analysis populations. Receives: Device: OCS Lung System |
What is being measured
The primary outcome is the main question the study is designed to answer.
12-month patient and graft survival post double-lung transplant
Primary Effectiveness Endpoint
Measured: 12 months
Secondary outcomes (5)
Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs
Lung ischemic time
Measured: 2 hours
Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)
Primary Graft Dysfunction
Measured: 0, 24, 48 and 72 hours
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation
Primary Graft Dysfunction
Measured: 72 hours
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate
Utilization Rate
Measured: 1 hour
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation
Primary Graft Dysfunction
Measured: Within 72 hours post-transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2018
- Study start10 Dec 2018
- Primary completion30 Nov 2025 (estimated)
- Study completion30 Nov 2029 (estimated)
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.
- 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
- 458 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03639025
- Sponsor's protocol ID
- OCS-LUN-PAS01
- Acronym
- TOP
- Status last verified
- Aug 2025
- First submitted
- 16 Aug 2018
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Organ Care System (OCS™) Lung Thoracic Organ Perfusion (TOP) Registry for Donor Lungs for Transplantation
- ClinicalTrials.gov ID
- NCT03639025
- Acronym / sponsor ID
- TOP / OCS-LUN-PAS01
- Conditions
- Lung Transplantation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 458 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 10 Dec 2018 (actual)
- Primary completion
- 30 Nov 2025 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 20 Aug 2018 (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.
Single-arm, prospective, multi-center, post-approval U.S. registry
Detailed description
This is an all-comers registry that will enroll:
- Patients who receive OCS™ preserved double lung transplants from either standard criteria donors or donors initially deemed unacceptable; and
- Patients who receive a single lung transplant from OCS™ preserved lung pairs from either standard criteria donors or donors initially deemed unacceptable; and
- All donor lungs that were perfused on OCS Lung System.
Enrolled patients will fall into one of the following three possible analysis categories:
- TOP SCDL PAS Primary Analysis Population: will be comprised of recipients transplanted with SCDL primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- TOP DLIDU Primary Analysis Population: Will be comprised of recipients transplanted with DLIDU primary analysis population eligible donor lungs preserved on the OCS™ Lung System.
- All Other Enrolled Patients: will be comprised of all OCS Lung transplanted patients in the TOP Registry that do not meet any of the above analysis populations.
Patient enrollment in the TOP Registry will continue until 266 eligible DLIDU Primary Analysis Population recipients have been enrolled.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Donor Lungs Primary Analysis Population | – | Device: OCS Lung SystemRecipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
| Donor Lungs Initially Unacceptable Primary Analysis Pop. | – | Device: OCS Lung SystemRecipients transplanted with primary analysis population eligible donor lungs preserved on the OCS™ Lung System. |
| All Other Enrolled Patients | – | Device: OCS Lung SystemAll OCS Lung transplanted patients that do not meet any of the above analysis populations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All lung transplant recipients whose donor lungs were preserved on the OCS™ Lung System
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 SystemThe OCS™ Lung System is a portable organ perfusion, ventilation, and monitoring medical device intended to preserve donor lungs in a near physiologic, ventilated, and perfused state prior to transplantation. This technology was designed to overcome the limitation of cold storage and has the potential to expand the utilization of donor lungs. The OCS™ Lung System accomplishes this by performing 3 key functions: * Reducing ischemic injury through the use of warm, oxygenated blood based perfusion. * Optimizing the lung condition by ventilatory recruitment maneuvers and high-oncotic perfusion solution supplemented with hormones and nutrients. * Allowing for ex-vivo functional assessment of the donor lung during preservation and prior to transplant. | Device | All Other Enrolled Patients, Donor Lungs Initially Unacceptable Primary Analysis Pop., Standard Donor Lungs Primary Analysis Population |
Primary outcome
12-month patient and graft survival post double-lung transplant
Time frame: 12 months
Primary Effectiveness Endpoint
5 secondary outcomes
Standard Criteria Donor Lungs - Total ischemic time for OCS™-preserved lungs
Time frame: 2 hours
Standard Criteria Lungs - Incidence of Primary Graft Dysfunction (PGD) grade 3 within the initial 72 hours post-transplantation (T0, T24, T48, and T72 hours)
Time frame: 0, 24, 48 and 72 hours
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 at 72 hours post-transplantation
Time frame: 72 hours
Donor Lungs Initially Deemed Unacceptable - Donor Lung Utilization Rate
Time frame: 1 hour
Donor Lungs Initially Deemed Unacceptable - Incidence of PGD3 within the initial 72 hours post-transplantation
Time frame: Within 72 hours post-transplantation
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 27 Aug 2025.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
18 sites 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 TransMedics at 18 sites 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 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites 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?
12-month patient and graft survival post double-lung transplant (time frame: 12 months). 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 Aug 2025.