Hôpital Louis-Pasteur (Cherbourg-Octeville)
Cherbourg-Octeville, 50102, France
NCT Number: NCT01783626
Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).
Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Cherbourg-Octeville, 50102, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: Change from T0 (dialysis start) at T4 hours (dialysis stop)
Time frame: Change from T0 (dialysis start) at T 4hours (dialysis stop)
Time frame: at T4 hours
Time frame: during the study period
Time frame: At T4 hours
Time frame: At T4 hours
Time frame: Change from T0 and T4 hours
Vantive Health LLC
Industry
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +) - A Prospective, Monocenter, Open and Non-randomized Pilot Study
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