Ignite Creation Date:
2024-05-05 @ 4:46 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00309348
Status:
COMPLETED
Last Update Posted:
2017-09-27
First Post:
2006-03-30
Brief Title:
Ultrasound Instrument to Prevent Dialysis Graft Failure
Sponsor:
DVX LLC
Organization:
DVX LLC
Study Overview
Official Title:
New Doppler Instrument for Preventing Impending Access-Graft Failure Randomized Trial
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
Detailed Description:
Vascular access failure is one of the largest causes of morbidity for chronic hemodialysis patients 16-25 of hospital admissions among United States end-stage renal disease ESRD patients are related to vascular access complications and the associated cost is estimated to be over one billion dollars per year
The most frequent cause of AV access-graft failure is thrombosis that occurs as a result of stenosis at or near the venous anastomosis Over 50 of existing vascular access-grafts in the US are 6 mm PTFE tubes and their thrombosis rate is much higher than that of native Arteriovenous Fistulas AVF
Several studies have shown that early detection and repair of stenosis can prevent access thrombosis reducing the morbidity and costs that follow thrombosis The cost of duplex ultrasound for access monitoring is prohibitive Blood flow measured by indicator-dilution methods seems to be a reliable indicator of impending access failure but recent randomized controlled studies intended to examine this were equivocal
This study funded by the NIH 2R44 DK067775 is to determine if a new instrument to monitor access blood-flow can reduce graft failure and associated costs In a pilot study using the new Doppler ultrasound instrument for weekly monitoring conducted by the Renal Research Institute and funded by the NIH the method predicted impending graft failure with 80 sensitivity and a false-alarm rate of less than 5year It measures access blood flow in less than three minutes and uses almost no consumables
This study is designed to test if monitoring with the new instrument improves health and reduces cost for hemodialysis patients with access-grafts
The most frequent cause of AV access-graft failure is thrombosis that occurs as a result of stenosis at or near the venous anastomosis Over 50 of existing vascular access-grafts in the US are 6 mm PTFE tubes and their thrombosis rate is much higher than that of native Arteriovenous Fistulas AVF
Several studies have shown that early detection and repair of stenosis can prevent access thrombosis reducing the morbidity and costs that follow thrombosis The cost of duplex ultrasound for access monitoring is prohibitive Blood flow measured by indicator-dilution methods seems to be a reliable indicator of impending access failure but recent randomized controlled studies intended to examine this were equivocal
This study funded by the NIH 2R44 DK067775 is to determine if a new instrument to monitor access blood-flow can reduce graft failure and associated costs In a pilot study using the new Doppler ultrasound instrument for weekly monitoring conducted by the Renal Research Institute and funded by the NIH the method predicted impending graft failure with 80 sensitivity and a false-alarm rate of less than 5year It measures access blood flow in less than three minutes and uses almost no consumables
This study is designed to test if monitoring with the new instrument improves health and reduces cost for hemodialysis patients with access-grafts
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R44DK067775 | NIH | None | httpsreporternihgovquickSearchR44DK067775 |