Home With TablO outcoMEs (HOME) Registry

NCT ID: NCT04526301

Last Updated: 2022-09-23

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-14

Study Completion Date

2024-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Tablo Hemodialysis System

Home dialysis treatment with the Tablo Hemodialysis System

Tablo Hemodialysis System

Intervention Type DEVICE

Home hemodialysis treatments \~4 times a week.

Interventions

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Tablo Hemodialysis System

Home hemodialysis treatments \~4 times a week.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Outset Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Satellite Healthcare, Inc.

San Jose, California, United States

Site Status RECRUITING

Desert Cities Dialysis

Victorville, California, United States

Site Status COMPLETED

Berkshire Medical Center

Pittsfield, Massachusetts, United States

Site Status RECRUITING

St. Peter's Health

Helena, Montana, United States

Site Status RECRUITING

Dialysis Center of Lincoln

Lincoln, Nebraska, United States

Site Status RECRUITING

Parker Jewish Institute

New Hyde Park, New York, United States

Site Status RECRUITING

NYU Grossman School of Medicine

New York, New York, United States

Site Status RECRUITING

Rogosin Institute

New York, New York, United States

Site Status RECRUITING

USRC Kidney Research

Plano, Texas, United States

Site Status RECRUITING

University of Virginia

Staunton, Virginia, United States

Site Status WITHDRAWN

Countries

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United States

Central Contacts

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Josh Schumacher

Role: CONTACT

(669) 231-8200

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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