The clinical investigation will be performed to generate clinical data on clearances and removal rates (for ß2-microglobulin, myoglobin, phosphate, creatinine, and urea) as well as biocompatibility of the modified polysulfone membrane to obtain CE-certification according to the European Medical Device Directive for the FX Coral 600 (TD 16-1) dialyzer.
The FX Coral (TD 16-1) dialyzer is a new development with a modified polysulfone membrane and is not CE marked yet. The purpose of the clinical evaluation is to generate clinical data for the CE approval.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
49
Three hemodiafiltration sessions assigned to one type of dialyzer FX Coral 600, FX 600 and FX CorDiax 600
Georg-Haas-Dialysezentrum der PHV
Giessen, Germany
Removal rate of 2-microglobulin
Removal rate of 2-microglobulin will be calculated as primary endpoint in blood samples to evaluate the clinical performance of the new FX Coral 600 (TD 16-1) dialyzer.
Time frame: t=240 min. of HDF
Clearance of ß2-microglobulin
Time frame: t=60 min. of HDF
Removal rates of myoglobin
Time frame: t=240 min. of HDF
Clearances of myoglobin
Time frame: t= 60 min. of HDF
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