Hemodialysis Clinical Trial
Official title:
New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial
Verified date | September 2017 |
Source | DVX, LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 111 |
Est. completion date | April 30, 2008 |
Est. primary completion date | April 30, 2008 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Chronic hemodialysis patients with an AV access graft Exclusion Criteria: - Anticipated change in renal replacement modality or geographic location - Inability to give informed consent - Anticipated life expectancy of less than one year |
Country | Name | City | State |
---|---|---|---|
United States | Queens Artificial Kidney Center | Jackson Heights | New York |
United States | St Albans Dialysis Center | Jamaica | New York |
Lead Sponsor | Collaborator |
---|---|
DVX, LLC | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Renal Research Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 |
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