Home With TablO outcoMEs (HOME) Registry

Outset Medical500 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

500

Conditions

End Stage Renal Disease

Interventions

Tablo Hemodialysis SystemDEVICE

Home hemodialysis treatments \~4 times a week.

Eligibility

Sex: ALLMin age: 15 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (10)

Satellite Healthcare, Inc.

San Jose, California, United States

RECRUITING

Desert Cities Dialysis

Victorville, California, United States

COMPLETED

Berkshire Medical Center

Outcomes

Primary Outcomes

Weekly Standardized Dialysis Adequacy

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.

Time frame: 12-months

Central Contacts

Josh Schumacher

CONTACT

(669) 231-8200 ClinicalTeam@outsetmedical.com

Data from ClinicalTrials.gov

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