Ultrasound Instrument to Prevent Dialysis Graft Failure

Completed · Not applicable

Conditions studied: Hemodialysis

In brief

This research study aims to show that a newly developed investigational Doppler instrument can reliably measure blood flow in dialysis access grafts, to see if a decrease in the flow may be a sign of impending graft failure and also to see if there is evidence that by monitoring the flow in these grafts their lives may be extended. The new investigational device is to be known as FloMon; this is an ultrasonic device that provides blood flow measurements from a small probe placed in a noninvasive manner above the graft or blood vessel. The instrument is being developed so that it may help give insight to on-coming graft failure which may be prevented. The FloMon is an extension of a previously Food and Drug Administration (FDA) cleared instrument, Echoflow-A, which had been used in a similar study as this one. The Echoflow-A is similar to this device in all respects with the exception of design and calculation of measurement. The FloMon compared to the Echoflow-A is better ergonomically designed and reads flow readings in about 2 minutes versus twice the time necessary to take similar measurements using the Echoflow-A.

Key facts

Study ID

NCT00309348

Run by

DVX, LLC

People needed

111

Starts

2006-02-27

Expected to finish

2008-04-30

Last updated by the study team

2017-09-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Chronic hemodialysis patients with an AV access graft

You may not qualify if…

• Anticipated change in renal replacement modality or geographic location
• Inability to give informed consent
• Anticipated life expectancy of less than one year

Where it is running

• Queens Artificial Kidney Center — Jackson Heights, New York, United States
• St Albans Dialysis Center — Jamaica, New York, United States

Full record on ClinicalTrials.gov

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