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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-12-31

Study Completion Date

2013-06-30

Brief Summary

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The SAVE Study will evaluate the safety and efficacy of the Venous Window Needle Guide in achieving access of a deep, un-cannulatable arteriovenous fistula to complete hemodialysis as prescribed.

Detailed Description

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Conditions

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End Stage Renal Disease AV Fistula Kidney Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Venous Window Needle Guide

Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula

Group Type EXPERIMENTAL

Venous Window Needle Guide

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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VWNG

Eligibility Criteria

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Inclusion Criteria

* Deep, uncannulatable, upper extremity arteriovenous fistula
* Minimum arteriovenous fistula flow 400 ml/min
* One year life expectancy

Exclusion Criteria

* Non-transposed basilic or brachial vein arteriovenous fistula
* History of peripheral vascular disease
* History of cardiovascular disease
* History of cerebral vascular disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Vital Access Corp.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

University of Oklahoma - Tulsa

Tulsa, Oklahoma, United States

Site Status

Countries

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United States

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.

Reference Type DERIVED
PMID: 24833247 (View on PubMed)

Other Identifiers

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VA 024

Identifier Type: -

Identifier Source: org_study_id

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