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Trial record 5 of 32 for:    Satellite Healthcare

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

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Outset Medical
ClinicalTrials.gov Identifier:
NCT02460263
First received: May 20, 2015
Last updated: October 3, 2016
Last verified: October 2016
  Purpose
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 Intervention
End Stage Renal Disease
Device: Tablo Hemodialysis System

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Outset Medical:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    weekly pre dialysis BUN and post dialysis BUN will be taken to calculate Kt/V


Estimated Enrollment: 50
Study Start Date: May 2015
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02460263

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

Responsible Party: Outset Medical
ClinicalTrials.gov Identifier: NCT02460263     History of Changes
Other Study ID Numbers: 2014-01 
Study First Received: May 20, 2015
Last Updated: October 3, 2016
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on December 05, 2016