Status:
UNKNOWN
Home With TablO outcoMEs (HOME) Registry
Lead Sponsor:
Outset Medical
Conditions:
End Stage Renal Disease
Eligibility:
All Genders
15+ years
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 14 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 31 2024
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT04526301
Start Date
July 14 2020
End Date
July 31 2024
Last Update
September 23 2022
Active Locations (10)
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1
Satellite Healthcare, Inc.
San Jose, California, United States, 95128
2
Desert Cities Dialysis
Victorville, California, United States, 92395
3
Berkshire Medical Center
Pittsfield, Massachusetts, United States, 01201
4
St. Peter's Health
Helena, Montana, United States, 59601