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

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)

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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