Safety and Efficacy Study of the Venous Window Needle Guide to Access Arteriovenous (AV)Fistulae (SAVE)

April 26, 2016 updated by: Vital Access Corp.

Vital Access Venous Window Needle Guide for Salvage of AV FistulaE (SAVE) Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

54

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Fresno, California, United States, 93710
        • Ladenheim Dialysis Access Centers
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • University of Oklahoma - Tulsa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Venous Window Needle Guide
Venous Window Needle Guide will be implanted onto deep, un-cannulatable arteriovenous fistula
Device: Venous Window Needle Guide
Subcutaneous, extravascular needle guide made of medical-grade titanium
Other Names:
  • VWNG

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Use of Venous Window Needle Guide to Obtain Arteriovenous Access for Hemodialysis
Time Frame: 3 months
Successful cannulation of arteriovenous fistula through the VWNG device and successful hemodialysis achieved within 3 months from index procedure.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Arteriovenous Fistula Cannulation Complications While Using the Venous Window Needle Guide
Time Frame: 6 months
Frequency of complications occuring when cannulating the arteriovenous fistula through the Venous Window Needle Guide
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vital Access Corp.

Investigators

  • Study Director: Mark Crawford, BA, Vital Access

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

November 1, 2011

First Submitted That Met QC Criteria

November 9, 2011

First Posted (Estimate)

November 11, 2011

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

April 26, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VA 024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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