Home With TablO outcoMEs (HOME) Registry (HOME)

September 22, 2022 updated by: Outset Medical
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • San Jose, California, United States, 95128
        • Recruiting
        • Satellite Healthcare, Inc.
        • Contact:
          • Kshama Mehta
        • Principal Investigator:
          • Wael Hussein, MD
      • Victorville, California, United States, 92395
        • Completed
        • Desert Cities Dialysis
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Recruiting
        • Berkshire Medical Center
        • Contact:
          • Tammy Bator, RN
        • Principal Investigator:
          • David Henner, M.D.
    • Montana
      • Helena, Montana, United States, 59601
        • Recruiting
        • St. Peter's Health
        • Contact:
          • Alice Luehr
        • Principal Investigator:
          • Robert LaClair, MD
    • Nebraska
      • Lincoln, Nebraska, United States, 68512
        • Recruiting
        • Dialysis Center of Lincoln
        • Contact:
          • Corinne Morehead
        • Principal Investigator:
          • Matt Glathar, MD
    • New York
      • New Hyde Park, New York, United States, 11040
        • Recruiting
        • Parker Jewish Institute
        • Contact:
          • Alana Doonacher
        • Principal Investigator:
          • Sayed Ali, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Grossman School of Medicine
        • Contact:
          • Paula Dutka
      • New York, New York, United States, 10021
        • Recruiting
        • Rogosin Institute
        • Principal Investigator:
          • Frank Liu, MD
        • Contact:
          • Kimberly Davis
    • Texas
      • Plano, Texas, United States, 75024
        • Recruiting
        • USRC Kidney Research
        • Contact:
          • Stephanie Brillhart, MSCI
        • Principal Investigator:
          • Geoff Block, MD
    • Virginia
      • Staunton, Virginia, United States, 24401
        • Withdrawn
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

11 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Tablo Hemodialysis System
Home dialysis treatment with the Tablo Hemodialysis System
Device: Tablo Hemodialysis System
Home hemodialysis treatments ~4 times a week.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Weekly Standardized Dialysis Adequacy
Time Frame: 12-months
Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
12-months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Health Outcomes
Time Frame: Change from Baseline at 12-months
Change in health outcomes from baseline to 12-months, as measured by the 12-item Short Form Health Survey (SF-12) Questionnaire. The questionnaire consists of 12 items weighted and summed to provide physical and mental health scores (PCS and MCS). The two composite scores are computed using the scores on twelve questions that range from 0 to 100. Higher scores mean a better outcome.
Change from Baseline at 12-months
Sleep Outcomes
Time Frame: Change from Baseline at 12-months
Change in sleep from baseline to 12-months, as measured by the Insomnia Severity Index (ISI). The minimum and maximum values are 0 and 28 scores, respectively. Higher scores mean a worse outcome.
Change from Baseline at 12-months
Care Partner Burden
Time Frame: Change from Baseline at 12-months
Change in care partner burden from baseline to 12-months, as measured by the Zarit Burden Interview-12 (ZBI-12) scale. The scale score is calculated by summing each item to produce a total score between 0 and 24, with higher scores indicating a worse outcome.
Change from Baseline at 12-months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Outset Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 14, 2020

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2024

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 24, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 25, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 23, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 22, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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