The purpose of this study is to evaluate the safety and efficacy of the Moda-flx Hemodialysis System™ when used Under Professional Care Settings by trained individuals and At Home by trained Participants and Care Partners
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
50
The Moda-flx Hemodialysis System™ is a portable hemodialysis system
North America Research Institute
San Dimas, California, United States
RECRUITINGNephrology Associates of Knoxville
Knoxville, Tennessee, United States
RECRUITINGaQua Research Institute, LLC
Houston, Texas, United States
RECRUITINGWeekly Standardized Dialysis Adequacy
Standardized weekly (stdKt/V) values as measured once every week during the Professional Care and At Home treatment settings
Time frame: Up to 10 weeks per period
Adverse Event (AE) Rate
The adverse event (AE) rate: defined as the number of Study Emergent AEs per 100 dialysis treatments occurring in the At Home period of the study, compared with those occurring during the Professional Care period.
Time frame: Up to 10 weeks per period
Goal Ultrafiltration Volume
Compliance with fluid removal goals that are defined as: Ultrafiltration (net fluid removal), such that the recorded value from the Moda-flx Hemodialysis System™ is within ± 100 mL/h or ± 250 mL (whichever is less) of set point during the treatment, based on the UF prescription.
Time frame: Up to 10 weeks per period
Study Emergent Pre-Specified Adverse Events
Study Emergent Pre-Specified Adverse Eventss, categorized by study period (Professional Care and At Home) severity, device relationship and procedure relationship. Study-emergent Pre-Specified AEs are those AEs with an onset on or after the date of first treatment during the Run-In Period, which will be comprised of any of the following: 1\. A composite of: * Serious Adverse Event * Allergic Reaction * Blood Loss * Hemolytic Reaction * Infection * Intradialytic Event * Vascular Access Complication * Pyrogenic Reaction
Time frame: Up to 10 weeks per period
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University of Washington
Seattle, Washington, United States
RECRUITING