Recruiting

Observational Study

Sponsor:

Outset Medical

Code:

NCT04526301

Conditions

End Stage Renal Disease

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Tablo Hemodialysis System

Study Details

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.

Conditions

End Stage Renal Disease

Study ID

NCT04526301

Start date

Jul 14, 2020

Status verified date

Aug, 2022

Completion date

Jul 31, 2024

Anticipated

Primary completion date

Jul 31, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Arms

Tablo Hemodialysis System

Home dialysis treatment with the Tablo Hemodialysis System

Interventions

Tablo Hemodialysis System

Home hemodialysis treatments \~4 times a week.

Primary outcome measure

  • Weekly Standardized Dialysis Adequacy [ Time Frame: 12-months ]

Central Contacts and Locations

Central contacts

Josh Schumacher

(669) 231-8200ClinicalTeam@outsetmedical.com

Locations

Satellite Healthcare, Inc.

Recruiting

San Jose, California, United States, 95128

Principal Investigator:

Wael Hussein, MD

Berkshire Medical Center

Recruiting

Pittsfield, Massachusetts, United States, 01201

Principal Investigator:

David Henner, M.D.

St. Peter's Health

Recruiting

Helena, Montana, United States, 59601

Principal Investigator:

Robert LaClair, MD

Dialysis Center of Lincoln

Recruiting

Lincoln, Nebraska, United States, 68512

Principal Investigator:

Matt Glathar, MD

Parker Jewish Institute

Recruiting

New Hyde Park, New York, United States, 11040

Principal Investigator:

Sayed Ali, MD

NYU Grossman School of Medicine

Recruiting

New York, New York, United States, 10016

Principal Investigator:

Naveed Masani, MD

Rogosin Institute

Recruiting

New York, New York, United States, 10021

Principal Investigator:

Frank Liu, MD

USRC Kidney Research

Recruiting

Plano, Texas, United States, 75024

Principal Investigator:

Geoff Block, MD

More Information

Sponsor

Outset Medical

Last update posted

Sep 23, 2022

Last verified

Aug, 2022

Keywords

  • Tablo
  • Outset Medical
  • ESRD
  • Home Hemodialysis
  • HHD
  • ESKD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Outset Medical on 2022-09-23.