Moda-flx Hemodialysis System™ Under Professional Care Settings by Trained Individuals and At Home by Participants

Part of paid clinical trials in San Dimas, California.

Sponsor
Diality Inc.
Study ID
NCT06613568
Status
Recruiting

Conditions

  • End Stage Kidney Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Moda-flx Hemodialysis System™ — DEVICE
    The Moda-flx Hemodialysis System™ is a portable hemodialysis system

Study Details

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

Key Dates

Start date
Oct 6, 2025
Status verified
Aug 2025
Primary completion
Mar 31, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Professional Care and At Home
    Participants will receive dialysis therapy using the Moda-Flx Hemodialysis System™ in a Professional Care setting and At Home setting

Primary Outcome Measure

Weekly Standardized Dialysis Adequacy [ Time Frame: Up to 10 weeks per period ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
North America Research InstituteSan DimasCalifornia91773
Molly Way
(800) 797-1695
Nephrology Associates of KnoxvilleKnoxvilleTennessee37920
Benjamin Brooks
865-323-3382
aQua Research Institute, LLCHoustonTexas77058
Rhea Sharma
281-939-6516
University of WashingtonSeattleWashington98104

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