A feasibility study of 7 chronic hemodialysis patients with difficult-to-access fistula undergoing implantation of the Venous Window Needle Guide to facilitate fistula access and development of buttonhole cannulation site.

Vital Access, Corp.0 sites7 target enrollmentStarted: May 25, 2010Last updated: January 13, 2020

Overview

No summary available.

•1\. Patient is currently successfully dialysed via existing A\-V fistula. 2\. AV Fistula diameter is at least 5mm at the site of device attachment. 3\. Buttonhole cannulation technique is appropriate. 4\. AV Fistula is or may be difficult to palpate or cannulate (short length, non\-palpable, limited fistula life expectancy, etc.). 5\. AV Fistula does not have flow abnormalities

•1\. Patient younger than 18 years of age
•2\. Skin infection at potential implant sites.
•3\. Pregnancy
•4\. Known bleeding disorder, e.g., low platelet count (\<50,000\), hypercoagulable state, e.g., antithrombin III deficiency; antiphospholipid or anticardiolipin antibodies; Factor V Leiden; circulating Lupus anticoagulant; current, active heparin\-induced thrombocytopenia; Protein C or S deficiency; or history of recurrent deep vein thrombosis not related to AV access.
•5\. Active malignancy, e.g., condition either being treated or considered untreatable
•6\. Active systemic infection, e.g., condition either being treated or considered untreatable
•7\. Uncontrolled major symptomatic medical problem, e.g., undiagnosed severe pain, metabolic disturbance, fever, etc.
•8\. Likelihood of poor compliance to required dialysis protocol, e.g., history of poor attendance to required clinic sessions or non\-compliance to medication
•9\. Mental incapacity; inability to understand treatment instructions
•10\. Currently participating in another investigational drug or device study that clinically interferes with the endpoints of this study

Sponsor

Vital Access, Corp.