The EvAluation of TaBlo In-CLinic and In-HOme

Completed · Not applicable

Conditions studied: End Stage Renal Disease

In brief

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.

Key facts

Study ID

NCT02460263

Run by

Outset Medical

People needed

30

Starts

2015-12-01

Expected to finish

2019-05-01

Last updated by the study team

2020-07-01

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Outset Medical — San Jose, California, United States

Full record on ClinicalTrials.gov

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