Feasibility Trial of the Venous Window Needle Guide - Surgical for Patients Who Have Difficult-to-Cannulate Native Arterial-Venous (A-V) Fistula for Hemodialysis

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.

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12610000416099

Acronym

Vital Access Needle Guide

Enrollment

Registered

2010-05-25

Start date

2010-06-11

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

The Venous Window Needle Guide is implanted onto the surface of an AV fistula by a vascular surgeon using a surgical technique. The skin will be closed over the implant. The duration of the surgical procedure will be approximately 30 minutes. Access of the AV fistula with a fistula needlle through the implant will be begin approximately three weeks following the intervention. Patients will be observed for six months post intervention.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

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

Outcome results