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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180014 / PAS001 |
| Date Original Protocol Accepted |
10/29/2019
|
| Date Current Protocol Accepted |
11/03/2021
|
| Study Name |
NOVEL/NOVEL Ext Cont Long Term PAS
|
| Device Name |
XPS™ with Steen Solution™ Perfusate
|
| Clinical Trial Number(s) |
NCT01365429
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
External Registry
|
| Comparison Group |
Concurrent & Historical Control
|
| Analysis Type |
Descriptive
|
| Study Population |
Transit. Adolescent A (distinctively) : 18-21 yrs,
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
The purpose of the XVIVO Registry is to collect standard of care clinical data from all comers who are transplanted with an EVLP lung treated with the XVIVO Perfusion System™ in order to assess the long-term performance of the device and monitor device-related serious adverse events. At the same time, a continuation study for the study subjects previously enrolled in the NOVEL and NOVEL Extension studies will be conducted to continue to capture long-term data on patients transplanted with donor lungs treated with the XPS System. These are single arm studies and the collected data will be compared to UNOS data on survival and primary graft dysfunction (PGD) at 72 hours post-transplantation, Bronchiolitis Obliterans Syndrome (BOS), FEV1, functional status and survival at 1, 2, 3, 4, and 5 years. The comparator data will be collected for all patients transplanted during the same time frame and from the same sites as the XVIVO Registry patients.
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| Study Population |
All comers (all patients receiving donor lungs treated with the XPS System)
|
| Sample Size |
All comers
Primary Effectiveness Endpoint:
Co-primary endpoints to be compared to control data:
Survival at 1 year post-transplantation;
Rate of Grade 3 PGD at 72 hours post-transplantation.
Secondary Effectiveness Endpoints:
Survival at 2, 3, 4, and 5 years post-transplantation for registry and control patients;
FEV1 at 1, 2, 3, 4, and 5 years post-transplantation per UNOS data collection (obtained from routine pulmonary function test performed closest to their anniversary);
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at 1, 2, 3, 4, and 5 years post-transplantation;
Hospitalizations from transplant to 1, 2, 3, 4, and 5 years post-transplantation;
Rejection episodes from transplant to 1, 2, 3, 4, and 5 years post-transplantation;
Quality of life at 1, 2, 3, 4, and 5 years post-transplantation:
Karnovsky Score;
Employment for income
|
| Key Study Endpoints |
Device-related serious adverse events from transplantation through 30 days post-transplantation, or initial hospital stay, whichever is longer.
Co-primary endpoints to be compared to control data:
Survival at 1 year post-transplantation;
Rate of Grade 3 PGD at 72 hours post-transplantation.
Secondary Effectiveness Endpoints
Survival at 2, 3, 4, and 5 years post-transplantation for registry and control patients;
FEV1 at 1, 2, 3, 4, and 5 years post-transplantation per UNOS data collection (obtained from routine pulmonary function test performed closest to their anniversary);
Incidence of Bronchiolitis Obliterans Syndrome (BOS) at 1, 2, 3, 4, and 5 years post-transplantation;
Number of hospitalizations from transplant to 1, 2, 3, 4, and 5 years post-transplantation;
Number of rejection episodes from transplant to 1, 2, 3, 4, and 5 years post-transplantation;
Quality of life at 1, 2, 3, 4, and 5 years post-transplantation:
Functional status;
Physical capacity.
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| Follow-up Visits and Length of Follow-up |
5 years
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