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First received: July 01, 2025

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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