Home With TablO outcoMEs (HOME) Registry

Outset Medical

Status

Enrolling

Conditions

End Stage Renal Disease

Treatments

Device: Tablo Hemodialysis System

Study type

Observational

Funder types

Industry

Identifiers

NCT04526301

2020-02

Details and patient eligibility

About

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.

Enrollment

500 estimated patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.