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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.
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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.
Inclusion
At least one of the following:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| OCS Preservation | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OCS Lung Preservation | Device | OCS Lung Preservation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Patient Survival | Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later. | 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. | Immediately at Transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Primary Graft Dysfunction Grade 3 | Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours | 72 hours post-transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Lung Graft-related Serious Adverse Events | Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject. | 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital and Medical Center | Phoenix | Arizona | 85013 | United States | ||
| UCLA Medical Center |
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Enrollment was stopped as a result of the FDA Approval of OCS Lung for the EXPAND indication.
51 Donor Lungs were instrumented on OCS Lung and 46 Donor Lungs were accepted and transplanted on study.
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| ID | Title | Description |
|---|---|---|
| FG000 | OCS Preservation | OCS Lung Preservation: OCS Lung Preservation |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | OCS Preservation | OCS Lung Preservation: OCS Lung Preservation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Recipient Age (years) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Survival | Patient survival at Day-30 post-transplantation or initial hospital discharge post-transplantation, whichever occurs later. | Posted | Count of Participants | Participants | 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant |
|
|
Lung graft related SAEs (LGRSAEs) data was collected for transplanted recipients through 30-days post-transplant or through the initial hospital stay, if longer than 30 days (a mean of 41.5 days post-transplant). All cause mortality is reported through 36-months post-transplant for all transplanted recipients.
Non-serious adverse events were not captured as part of this study. Only lung graft related SAEs and deaths were captured through investigator assessment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | OCS Preservation | OCS Lung Preservation: OCS Lung Preservation | 12 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Respiratory failure/protracted ventilation | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| VP, Clinical Affairs | TransMedics, Inc. | 978-552-0900 | ldamme@transmedics.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 18, 2017 | Dec 18, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 18, 2017 | Dec 18, 2023 | SAP_001.pdf |
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OCS Lung System
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| Los Angeles |
| California |
| 90095 |
| United States |
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| Stanford University Medical Center | Stanford | California | 94305 | United States |
| The Johns Hopkins Hospital | Baltimore | Maryland | 21287 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| University of Nebraska | Omaha | Nebraska | 68198 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | United States |
| Baylor St. Luke's Medical Center | Houston | Texas | 77030 | United States |
| Houston Methodist | Houston | Texas | 77030 | United States |
| University of Virginia | Charlottesville | Virginia | 22908 | United States |
| Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | United States |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Recipient Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
|
| Primary | 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. | 51 eligible donor lungs were instrumented on OCS. 46 donor lungs were accepted after perfusion and transplanted into recipients. | Posted | Count of Units | Lungs Instrumented on OCS | Immediately at Transplantation | Lungs Instrumented on OCS | Lungs Instrumented on OCS |
|
|
|
| Secondary | Primary Graft Dysfunction Grade 3 | Number of Participants with Primary Graft Dysfunction Grade 3 at T72 hours | Posted | Count of Participants | Participants | 72 hours post-transplant |
|
|
|
| Other Pre-specified | Number of Lung Graft-related Serious Adverse Events | Number of lung graft-related serious adverse events through the 30-day follow-up or until initial hospital admission (if longer than 30 days) after transplantation per subject. | Posted | Count of Participants | Participants | 30 days post-transplantation or initial hospital discharge post-transplantation, a mean of 41.5 days post-transplant |
|
|
|
| 46 |
| 16 |
| 46 |
| 0 |
| 0 |
| Major pulmonary-related infection | Infections and infestations | Systematic Assessment |
|
| Bronchial anastomotic complication | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Biopsy-proven moderate or severe acute rejection | General disorders | Systematic Assessment |
|
Site shall have right to publish results. To balance this right with TransMedics' (TM proprietary interests, site will submit manuscripts intended for publication for TM's review at least 30d prior to submission date. TM will complete its review within 30d of receipt. TM may request that site delete from its manuscripts any reference to TM confidential information and site shall promptly comply with such request. After 60d period, site will have right to publish manuscript, as amended by TM.