Expired Study
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Menlo Park, California 95126


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.


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.


NCT ID:

NCT02460263


Primary Contact:

Principal Investigator
Geoff Block, MD
Denver Nephrology


Backup Contact:

N/A


Location Contact:

Menlo Park, California 95126
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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