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

IRB Number

11-123

ClinicalTrials.gov Identifier

NCT01471041

Trial Status

Open for Enrollment
Phase 2

Why is this study being done?

The purpose of this study is to evaluate the safety and performance of the Venous Window Needle Guide (Study device). We hope to find out what effects, good and/or bad, the study device has on you and your ability to dialyze.

Who is eligible to participate?

Patients who have a dialysis fistula in one of their arms, which cannot be accessed for dialysis, are eligible for this study.

What is involved?

Patients will undergo physical examination, blood tests, and confirmation that the fistula cannot be accessed. They will then undergo the procedure to implant the Venous Window Needle Guide. After hospital discharge, patients will return for four follow-up clinic visits ranging from 3 weeks after the procedure to six months after the procedure.

How long is the study?

Patients will be in this study for approximately six months.

Who can I contact for additional information?

Please contact Tiffany Whitaker, R.N., at (217) 545-2531 or email:twhitaker@siumed.edu

Who is the Principal Investigator of this study?

Doug Hood, MD

Where is the trial located?

Springfield, Illinois