Lung TransplantationNCT03343535
OCS Lung System EXPAND II Trial
A study testing OCS Lung Preservation in people with Lung Transplantation, run by TransMedics at 14 sites in United States.
Trial summary
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Lung Transplantation
- What is being tested?
- OCS Lung Preservation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 14 sitesUnited States
- Study dates
- 12 Mar 2018to 6 Jul 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
- Participant in any other clinical or investigational trials/programs
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
Massachusetts General Hospital
Boston, Massachusetts, 02114
University of Virginia
Charlottesville, Virginia, 22908
Duke University Medical Center
Durham, North Carolina, 27710
Baylor St. Luke's Medical Center
Houston, Texas, 77030
Houston Methodist
Houston, Texas, 77030
UCLA Medical Center
Los Angeles, California, 90095
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
University of Minnesota
Minneapolis, Minnesota, 55455
University of Nebraska
Omaha, Nebraska, 68198
Temple University Hospital
Philadelphia, Pennsylvania, 19140
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013
University of California, San Francisco
San Francisco, California, 94143
Stanford University Medical Center
Stanford, California, 94305
About this study
Official title: Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Read the detailed description
Inclusion
At least one of the following:
- Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
- Expected cross-clamp time > 6 hours for the second lung; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥ 55 years old
- Conditions
- Lung Transplantation
- Being tested
- OCS Lung Preservation
- Keywords
- portable ex-vivo lung perfusion, breathing lung transplant, portable OCS Lung System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCS Lung PreservationDevice
Also called OCS Lung Transplant
OCS Lung Preservation
| Study group | Role | What they receive |
|---|---|---|
| OCS Preservation | Experimental | Not described Receives: Device: OCS Lung Preservation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Survival
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
Measured: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Donor Lung Utilization Rate
Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.
Measured: Immediately at Transplantation
Secondary outcomes (1)
Primary Graft Dysfunction Grade 3
Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours
Measured: 72 hours post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start12 Mar 2018
- Primary completion27 Aug 2019
- Study completion6 Jul 2022
Why it stopped: Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- OCS Lung System
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- TransMedics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03343535
- Sponsor's protocol ID
- OCS-LUN-012017
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2017
- Last updated
- 28 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- 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 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trial to Evaluate the Safety and Effectiveness of the Portable Organ Care System (OCS™) Lung System for Recruiting, Preserving and Assessing Non-Ideal Donor Lungs for Transplantation
- ClinicalTrials.gov ID
- NCT03343535
- Acronym / sponsor ID
- OCS-LUN-012017
- Conditions
- Lung Transplantation
- Keywords
- portable ex-vivo lung perfusion, breathing lung transplant, portable OCS Lung System
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment in EXPAND II was stopped June 24, 2019 as a result of the FDA approval for the EXPAND indication. Therefore, no additional sites or subjects were enrolled after that time.
- Enrolment
- 46 participants (actual)
- Lead sponsor
- TransMedicsIndustry (pharma, biotech, devices)
- Study start
- 12 Mar 2018 (actual)
- Primary completion
- 27 Aug 2019 (actual)
- Study completion
- 6 Jul 2022 (actual)
- First posted
- 17 Nov 2017 (actual)
- Results
- Posted 28 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the safety and effectiveness of the OCS™ Lung System to recruit, preserve and assess non-ideal donor lungs that may not meet current standard donor lung acceptance criteria for transplantation.
Detailed description
Inclusion
At least one of the following:
- Donor PaO2/FiO2 ≤ 300 mmHg at the time of the offer; or
- Expected cross-clamp time > 6 hours for the second lung; or
- Donor after Cardiac Death (DCD donor); or
- Donor age ≥ 55 years old
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- OCS Lung System
| Arm | Type | Receives |
|---|---|---|
| OCS Preservation | Experimental | Device: OCS Lung Preservation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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 (4 listed)
- Prior solid organ or bone marrow transplant
- Single lung recipient
- Chronic use of hemodialysis or renal replacement therapy for diagnosis of chronic renal dysfunction requiring dialysis
- Participant in any other clinical or investigational trials/programs
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 PreservationAlso: OCS Lung TransplantOCS Lung Preservation | Device | OCS Preservation |
Primary outcome
Patient Survival
Time frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant
Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later.
Donor Lung Utilization Rate
Time frame: Immediately at Transplantation
Donor lung utilization rate, defined as the number of donated lungs instrumented on OCS™ that meet inclusion/exclusion criteria for the trial and acceptance criteria for transplantation after OCS™ Lung assessment divided by the total eligible donor lungs instrumented on the OCS™ Lung System.
1 secondary outcome
Primary Graft Dysfunction Grade 3
Time frame: 72 hours post-transplant
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCS Lung Preservation in people with Lung Transplantation, run by TransMedics at 14 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?
The sponsor lists 3 inclusion and 4 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 28 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Yes. Results are posted in the registry (first posted 28 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Survival (time frame: 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant). 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 28 Feb 2024; AzTrials last refreshed its copy on 29 Oct 2026.