Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2020-07-14
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Tablo Hemodialysis System
Home dialysis treatment with the Tablo Hemodialysis System
Tablo Hemodialysis System
Home hemodialysis treatments \~4 times a week.
Interventions
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Tablo Hemodialysis System
Home hemodialysis treatments \~4 times a week.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
15 Years
ALL
No
Sponsors
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Outset Medical
INDUSTRY
Responsible Party
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Locations
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Satellite Healthcare, Inc.
San Jose, California, United States
Desert Cities Dialysis
Victorville, California, United States
Berkshire Medical Center
Pittsfield, Massachusetts, United States
St. Peter's Health
Helena, Montana, United States
Dialysis Center of Lincoln
Lincoln, Nebraska, United States
Parker Jewish Institute
New Hyde Park, New York, United States
NYU Grossman School of Medicine
New York, New York, United States
Rogosin Institute
New York, New York, United States
USRC Kidney Research
Plano, Texas, United States
University of Virginia
Staunton, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Kshama Mehta
Role: primary
Tammy Bator, RN
Role: primary
Alice Luehr
Role: primary
Corinne Morehead
Role: primary
Alana Doonacher
Role: primary
Paula Dutka
Role: primary
Kimberly Davis
Role: primary
Stephanie Brillhart, MSCI
Role: primary
Other Identifiers
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2020-02
Identifier Type: -
Identifier Source: org_study_id
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