Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae
NCT ID: NCT01471041
Last Updated: 2016-06-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2/PHASE3
54 participants
INTERVENTIONAL
2011-12-31
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Venous Window Needle Guide
Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Venous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium
Interventions
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Venous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Minimum arteriovenous fistula flow 400 ml/min
* One year life expectancy
Exclusion Criteria
* History of peripheral vascular disease
* History of cardiovascular disease
* History of cerebral vascular disease
18 Years
ALL
No
Sponsors
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Vital Access Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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Mark Crawford, BA
Role: STUDY_DIRECTOR
Vital Access
Locations
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Ladenheim Dialysis Access Centers
Fresno, California, United States
University of Oklahoma - Tulsa
Tulsa, Oklahoma, United States
Countries
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References
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Jennings WC, Galt SW, Shenoy S, Wang S, Ladenheim ED, Glickman MH, Kathuria P, Browne BJ. The Venous Window Needle Guide, a hemodialysis cannulation device for salvage of uncannulatable arteriovenous fistulas. J Vasc Surg. 2014 Oct;60(4):1024-32. doi: 10.1016/j.jvs.2014.04.016. Epub 2014 May 13.
Other Identifiers
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VA 024
Identifier Type: -
Identifier Source: org_study_id
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