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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180014 / PAS002 |
| Date Original Protocol Accepted |
10/29/2019
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| Date Current Protocol Accepted |
08/09/2023
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| Study Name |
Long Term Eval PAS of XPS System
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| Device Name |
XPS™ with Steen Solution™ Perfusate
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| General Study Protocol Parameters |
| Study Design |
Active Surveillance
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| Data Source |
External Registry
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| Comparison Group |
Concurrent Control
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| Analysis Type |
Descriptive
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| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The XVIVO Registry will collect standard-of-care outcome data and device-related safety data from transplant to one-year post-transplant, followed by standard of care and OPTN data collection at years 2, 3, 4, and 5.
In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
Registry Objectives
The purpose of the Registry is to monitor the real-world performance and safety of the XPS™ with STEEN Solution™ procedure for ex vivo lung perfusion (EVLP) of donor lungs for transplant.
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| Study Population |
All comers (all patients receiving donor lungs treated with the XPS System)
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| Sample Size |
An EVLP lung could be transplanted at any of the centers in the United States and will be identified through the OPTN perfusion and solution data fields. In addition, 4 and 5-year UNOS registry data of the 126 subjects who received an EVLP transplant under the NOVEL and NOVEL Extension studies are provided as part of the long-term safety and quality of life data.
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| Key Study Endpoints |
Primary Endpoints
The co-primary endpoints are to be compared to control data:
Survival at 1 year post-transplant.
Rate of Grade 3 primary graft dysfunction (PGD) at 72 hours post-transplant
Secondary Endpoints via UNOS
The secondary endpoints are:
Survival at 2, 3, 4 and 5 years post-transplant for registry and control patients
Remaining endpoints to be summarized for registry patients only
FEV1 from at 1, 2, 3, 4, and 5 years per UNOS data collection, (obtained from routine PFT closest to anniversary date).
Incidence of Bronchiolitis Obliterans Syndrome (BOS) or CLAD at 1, 2, 3, 4 and 5 years post- transplant.
If subject was hospitalized from transplant to 1, 2, 3, 4 and 5 years post-transplant.
If subject had rejection from transplant to 1, 2, 3, 4 and 5 years post-transplant.
Quality of Life based on OPTN data at 1, 2, 3, 4 and 5 years post-transplant.
Safety Endpoints
The Registry will collect all device-related serious adverse events from transplant to through 30 days post-transplant or initial hospital stay, whichever is longer.
All data collected for the registry is to be obtained from normal standard-of-care clinical practices and documentation. Registry and Control data will be provided to the sponsor from UNOS through a data use agreement. This data does not capture BOS, therefore XVIVO will request BOS evaluations and FEV1 (L) for CLAD evaluation and any other data clarifications with the transplant center or hospitals
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| Follow-up Visits and Length of Follow-up |
Functional status and survival at 1,2,3,4 and 5 years will be obtained for all patients transplanted during the same time frame and from the same sites as the EVLP registry patients.
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