|
General |
Study Status |
Terminated |
Application Number / Requirement Number |
H120003 / PAS001 |
Date Original Protocol Accepted |
04/07/2015
|
Date Current Protocol Accepted |
04/07/2015
|
Study Name |
Long-Term Study
|
Device Name |
XPS WITH STEEN SOLUTION PERFUSATE
|
General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
|
Data Source |
External Registry
|
Comparison Group |
Concurrent Control
|
Analysis Type |
Analytical
|
Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
|
Detailed Study Protocol Parameters |
Study Objectives |
The objective of this study is to demonstrate the XVIVO Perfusion System (XPS) with STEEN Solution can be safely used for the flushing and temporary continuous normothermic machine perfusion of initially unacceptable excised donor lungs during which time the function of the lungs can be reassessed for transplantation. The study is a prospective, multicenter, controlled clinical trial.
|
Study Population |
A total of 252 patients will include 220 from the premarket cohort and 32 newly enrolled patients. The treatment arm will consist of 126 who receive EVLP treated lungs that were initially unacceptable and the comparator arm will consist of 126 patients who are transplanted with standard lungs that are preserved with the cold storage method.
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Sample Size |
A total of 252 patients (126 per arm) will be included in the PAS.
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Key Study Endpoints |
The primary endpoint is 3 year survival rate. The secondary endpoints are quality of life, episodes of rejection per United Network for Organ Sharing (UNOS) registry, and Forced Expiratory Volume in 1 second (FEV1) at 1, 2, 3 years. Safety endpoint is the post transplant events captured in the UNOS Registry at 2, 3 years.
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Follow-up Visits and Length of Follow-up |
3 years (2nd and 3rd year with the UNOS Registry) Subjects will be followed for 3 years post transplant, with data collected at the 1, 2, and 3 year time points.
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