Clinical Trial: Premarket Clinical Safety Assessment of the ELISIO™-HX
Study Status: COMPLETED
Recruit Status: COMPLETED
Condition: Renal Failure
Study Type: INTERVENTIONAL
Official Title: Premarket Clinical Safety Assessment of the ELISIO™-HX
Brief Summary:
The primary safety objective of this study is to evaluate the safety of the use of the high-permeability hemodialyzer series ELISIO™-HX, by showing that the pre-dialysis albumin levels are not affected using the investigational dialyzer.The primary efficacy objective is to evaluate the performance of the use of the high permeability hemodialyzer series ELISIO™-HX, by showing that the clearance rate of middle molecular weight lambda (?) free light chain (FLC) is improved by using the investigational dialyzer.
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