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Home With TablO outcoMEs (HOME) Registry (HOME)

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ClinicalTrials.gov Identifier: NCT04526301
Recruitment Status : Recruiting
First Posted : August 25, 2020
Last Update Posted : September 9, 2021
Sponsor:
Information provided by (Responsible Party):
Outset Medical

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.

Condition or disease Intervention/treatment
End Stage Renal Disease Device: Tablo Hemodialysis System

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Year
Official Title: Home With TablO outcoMEs (HOME) Registry
Actual Study Start Date : July 14, 2020
Estimated Primary Completion Date : January 31, 2023
Estimated Study Completion Date : January 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Group/Cohort Intervention/treatment
Tablo Hemodialysis System
Home dialysis treatment with the Tablo Hemodialysis System
Device: Tablo Hemodialysis System
Home hemodialysis treatments ~4 times a week.




Primary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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.



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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with end stage renal disease (ESRD) who are on, or planning to be on, maintenance hemodialysis.
Criteria

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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04526301


Contacts
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Contact: Josh Schumacher (669) 231-8200 ClinicalTeam@outsetmedical.com

Locations
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United States, California
Satellite Healthcare, Inc. Recruiting
San Jose, California, United States, 95128
Contact: Kshama Mehta         
Principal Investigator: Wael Hussein, MD         
Desert Cities Dialysis Recruiting
Victorville, California, United States, 92395
Contact: Jennifer Stolpp         
Principal Investigator: Prashanth V Kumar, MD         
United States, Massachusetts
Berkshire Medical Center Recruiting
Pittsfield, Massachusetts, United States, 01201
Contact: Tammy Bator, RN         
Principal Investigator: David Henner, M.D.         
United States, Montana
St. Peter's Health Recruiting
Helena, Montana, United States, 59601
Contact: Alice Luehr         
Principal Investigator: Robert LaClair, MD         
United States, Nebraska
Dialysis Center of Lincoln Recruiting
Lincoln, Nebraska, United States, 68512
Contact: Corinne Morehead         
Principal Investigator: Matt Glathar, MD         
United States, New York
Queens Long Island Renal Institute Recruiting
New Hyde Park, New York, United States, 11040
Contact: Bonita Waites         
Principal Investigator: Sayed Ali, MD         
NYU Grossman School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Paula Dutka         
Principal Investigator: Naveed Masani, MD         
Rogosin Institute Recruiting
New York, New York, United States, 10021
Contact: Kimberly Davis         
Principal Investigator: Frank Liu, MD         
United States, Virginia
University of Virginia Recruiting
Staunton, Virginia, United States, 24401
Contact: Liz Kurland, BA, CCRC         
Principal Investigator: Emaad M Abdel-Rahman, MD         
Sponsors and Collaborators
Outset Medical
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Responsible Party: Outset Medical
ClinicalTrials.gov Identifier: NCT04526301    
Other Study ID Numbers: 2020-02
First Posted: August 25, 2020    Key Record Dates
Last Update Posted: September 9, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Outset Medical:
Tablo
Outset Medical
ESRD
Home Hemodialysis
HHD
ESKD
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency