Trial record 5 of 18 for:    Satellite Healthcare

The EvAluation of TaBlo In-CLinic and In-HOme (TABLO)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02460263
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2015
Last Update Posted : October 4, 2016
Information provided by (Responsible Party):
Outset Medical

Brief Summary:
The purpose of this study is to evaluate the Tablo Hemodialysis System when used In-Center by trained individuals and In-Home by trained Subjects.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Device: Tablo Hemodialysis System Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Multicenter, Open Label, Non-Randomized, Cross-Over Study Evaluating the Use of the Tablo Hemodialysis System In-Center and In-Home by Subjects With End Stage Renal Disease (ESRD) Who Are on Stable Dialysis Regimens
Study Start Date : May 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: In-Center
Staff administered treatments in-center using the device
Device: Tablo Hemodialysis System
Experimental: In-Home
Patient administered treatments in-home using the device
Device: Tablo Hemodialysis System

Primary Outcome Measures :
  1. Delivery of a standardized weekly Kt/V of greater than or equal to 2.1 [ Time Frame: weekly for 8 weeks per treatment period for up to 19 weeks ]
    weekly pre dialysis BUN and post dialysis BUN will be taken to calculate Kt/V

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Subject has end stage renal disease (ESRD) adequately treated by maintenance dialysis achieving a Kt/V ≥ 1.2 and has been deemed stable for at least three months by his/her treating nephrologist.
  • Subject has a well-functioning and stable vascular access that allows a blood flow of at least 300 ml/min.

Exclusion Criteria:

  • Life expectancy less than 12 months from first study procedure.
  • Subject has had a recent major cardiovascular adverse event within the last 3 months.
  • Subject has New York Class III or IV Congestive Heart Failure, or ejection fraction less than 30%.
  • Subject with fluid overload due to intractable ascites secondary to liver cirrhosis.
  • Subject has uncontrolled blood pressure.
  • Subject is intolerant to heparin.
  • Subject is seroreactive for Hepatitis B Surface Antigen.
  • Subject has an active, life-threatening, rheumatologic disease.
  • Subject has a history of adverse reactions to dialyzer membrane material.
  • Subject is expected to receive an organ transplant during the course of the study.
  • Subject has a life-threatening malignancy actively receiving treatment that would prevent successful completion of the study protocol.

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 identifier (NCT number): NCT02460263

United States, California
Satellite Healthcare
Menlo Park, California, United States, 95126
Sponsors and Collaborators
Outset Medical
Principal Investigator: Geoff Block, MD Denver Nephrology

Responsible Party: Outset Medical Identifier: NCT02460263     History of Changes
Other Study ID Numbers: 2014-01
First Posted: June 2, 2015    Key Record Dates
Last Update Posted: October 4, 2016
Last Verified: October 2016

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency