Home With TablO outcoMEs (HOME) Registry
- Conditions
- End Stage Renal Disease
- Interventions
- Device: Tablo Hemodialysis System
- Registration Number
- NCT04526301
- Lead Sponsor
- Outset Medical
- Brief Summary
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 500
- Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- Participant weighs ≥ 34kg.
- Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
- Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
- Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.
- Participant and/or care partner is unable to read English or Spanish.
- Participant has a home environment that is deemed inappropriate for home dialysis.
- Participant and/or care partner is unable to successfully complete the Tablo training program
- Participant is pregnant or plans to become pregnant.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Tablo Hemodialysis System Tablo Hemodialysis System Home dialysis treatment with the Tablo Hemodialysis System
- Primary Outcome Measures
Name Time Method Weekly Standardized Dialysis Adequacy 12-months Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (10)
Dialysis Center of Lincoln
🇺🇸Lincoln, Nebraska, United States
St. Peter's Health
🇺🇸Helena, Montana, United States
Satellite Healthcare, Inc.
🇺🇸San Jose, California, United States
Desert Cities Dialysis
🇺🇸Victorville, California, United States
Berkshire Medical Center
🇺🇸Pittsfield, Massachusetts, United States
Parker Jewish Institute
🇺🇸New Hyde Park, New York, United States
NYU Grossman School of Medicine
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Staunton, Virginia, United States
USRC Kidney Research
🇺🇸Plano, Texas, United States
Rogosin Institute
🇺🇸New York, New York, United States