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

O

Outset Medical

Status

Completed

Conditions

End Stage Renal Disease

Treatments

Device: Tablo Hemodialysis System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02460263
2014-01

Details and patient eligibility

About

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.

Enrollment

30 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

30 participants in 2 patient groups, including a placebo group

In-Center
Placebo Comparator group
Description:
Staff administered treatments in-center using the device
Treatment:
Device: Tablo Hemodialysis System
In-Home
Experimental group
Description:
Patient administered treatments in-home using the device
Treatment:
Device: Tablo Hemodialysis System

Trial documents
2

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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