Ultrasound Instrument to Prevent Dialysis Graft Failure

NCT00309348 | Completed

• 1 other identifier: R44DK067775
• Study Type: interventional
• Target: 111
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hemodialysis

Outcome Measures

Primary Outcomes (1)

• Number of low flow events

  A "Low-Flow Event" is an intervention, whether an angioplasty or thrombectomy, to increase graft flow.

  Mean follow-up of 15 months

Study Arms (2)

Weekly measurement of graft flow

EXPERIMENTAL

The surveillance group was measured with the FloMon instrument weekly, and all procedures related to their access-grafts recorded

Other: Weekly measurement of graft flow

Control

NO INTERVENTION

The control group was questioned weekly with regard to their graft status and whether there had been any graft-related procedures

Interventions

Weekly measurement of graft flow OTHER

Weekly measurement of graft flow

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• DVX, LLC: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator
• Renal Research Institute: collaborator

Study Sites (2)

Queens Artificial Kidney Center

Jackson Heights, New York, 11372, United States

Location

St Albans Dialysis Center

Jamaica, New York, 11434, United States

Location

Study Officials

• Nathan Levine, MD

  Renal Research Institute

  PRINCIPAL INVESTIGATOR

• David Vilkomerson, PhD

  DVX, LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2006
• First Posted: March 31, 2006
• Study Start: February 27, 2006
• Primary Completion: April 30, 2008
• Study Completion: April 30, 2008
• Last Updated: September 27, 2017

Record last verified: 2017-09

Locations

US (2)