Trial Search Results

The EvAluation of TaBlo In-CLinic and In-HOme

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.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Outset Medical

Stanford Investigator(s):

Intervention(s):

  • Device: Tablo Hemodialysis System

Phase:

N/A

Eligibility


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.

Ages Eligible for Study

18 Years - 75 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Recruiting