Lung TransplantNCT06513091
US National TOP Registry
An observational study of Lung Transplant, run by TransMedics at 7 sites in United States.
Trial summary
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Transplant
- What is being tested?
- OCS Lung
- Type of treatment
- Medical device
- How many people
- 10,000 participants
- Where
- 7 sitesUnited States
- Study dates
- 23 Jan 2025to Nov 2039
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.
All lung transplant recipients
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Kausar Qidwai contact
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Baylor Scott & White Research Institute
Dallas, Texas, 75246
Erin Lee, 214-818-7621, Erin.Lee@BSWHealth.org
Gary Schwartz, MD
- Recruiting
Duke University
Durham, North Carolina, 27705
Sarah Casalinova, sarah.casalinova@duke.edu
Matthew Hartwig, MD
- Recruiting
Baylor College of Medicine
Houston, Texas, 77030
Andres Leon Pena, MD, 713-798-7533, andres.leonpena@bcm.edu
Gabriel Loor, MD
- Recruiting
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Kelly Potzner
Lucian Durham, MD, PhD
- Recruiting
University of Minnesota
Minneapolis, Minnesota, 55455
Nicholas Lemke, ntlemke@umn.edu
Stephen Huddleston, MD PhD
- Recruiting
St. Joseph's Hospital & Medical Center
Phoenix, Arizona, 85013
Brian Mutoff, brian.mutoff@commonspirit.org
Michael Smith, MD
- Recruiting
Stanford University School of Medicine
Stanford, California, 94305
Tiffany Koyano, 650-206-0141, tkoyano3@stanford.edu
Anson Lee, MD
About this study
Official title: US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
The objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.
- Conditions
- Lung Transplant
- Being tested
- OCS Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS LungDevice
The TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system.
| Study group | Role | What they receive |
|---|---|---|
| OCS Lung Transplant Recipients | The US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry. Receives: Device: OCS Lung | |
| Non-OCS Lung Transplant Recipients | Patients transplanted using other preservation modalities for benchmarking clinical outcomes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
One-year patient and graft survival
Recipients' one-year patient and graft survival rates
Measured: 1-year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2024
- Study start23 Jan 2025
- Primary completionNov 2034 (estimated)
- Study completionNov 2039 (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
- Other
- Time perspective
- Other
- Enrolment
- 10,000 participants (estimated)
- 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
- NCT06513091
- Sponsor's protocol ID
- OCS-LUN-TOP-II
- Status last verified
- Feb 2025
- First submitted
- 12 Jul 2024
- Last updated
- 3 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- US National OCS Lung Thoracic Organ Perfusion (TOP) Registry
- ClinicalTrials.gov ID
- NCT06513091
- Acronym / sponsor ID
- OCS-LUN-TOP-II
- Conditions
- Lung Transplant
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2025 (actual)
- Primary completion
- Nov 2034 (estimated)
- Study completion
- Nov 2039 (estimated)
- First posted
- 22 Jul 2024 (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 objective of this Registry is to collect short and long-term post-transplant clinical outcome data of all donor lungs preserved and assessed on the OCS Lung System and to document the performance of the OCS device in the real-world setting after FDA approval in the US.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OCS Lung Transplant Recipients | – | Device: OCS LungThe US National TOP Registry will enroll all liver transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry. |
| Non-OCS Lung Transplant Recipients | – | –Patients transplanted using other preservation modalities for benchmarking clinical outcomes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The US National TOP Registry will enroll all lung transplant recipients who are transplanted with OCS-perfused donor lung(s) in the Registry, as well as patients transplanted using other preservation modalities for benchmarking clinical outcomes.
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 LungThe TransMedics Organ Care System (OCS) Lung is an FDA approved portable extracorporeal lung perfusion and monitoring system. | Device | OCS Lung Transplant Recipients |
Primary outcome
One-year patient and graft survival
Time frame: 1-year post-transplant
Recipients' one-year patient and graft survival rates
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 3 Sep 2025.
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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.
Kausar Qidwai contact
7 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 Transplant, run by TransMedics at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Contact Julia Church (9782893546, jdeane@transmedics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
One-year patient and graft survival (time frame: 1-year post-transplant). 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 3 Sep 2025.