Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000416099
Ethics application status
Not yet submitted
Date submitted
20/05/2010
Date registered
25/05/2010
Date last updated
25/05/2010
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility Trial of the Venous Window Needle Guide - Surgical for Patients Who Have Difficult-to-Cannulate Native Arterial-Venous (A-V) Fistula for Hemodialysis
Scientific title
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.
Secondary ID [1] 251803 0
N/A
Universal Trial Number (UTN)
Trial acronym
Vital Access Needle Guide
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Difficult to cannulate AV fistula for chronic hemodialysis. 256807 0
Condition category
Condition code
Renal and Urogenital 256957 256957 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 256012 0
Treatment: Devices
Intervention code [2] 256541 0
Treatment: Surgery
Comparator / control treatment
Patients will have both intervention and non-intervention A-V fistula access sites. The non-intervention access site will act as the comparator access site to the intervention access site.
Control group
Active

Outcomes
Primary outcome [1] 257837 0
AV fistula access through Venous Window Needle Guide utilizing buttonhole cannulation technique resulting in hemodialysis session within normal pressure and flow parameters.
Timepoint [1] 257837 0
3 months post intervention
Secondary outcome [1] 263251 0
Successful placement of study device, defined as placement of the Venous Window Needle Guide with proper attachment, alignment and palpability on a native A-V fistula in an upper extremity
Timepoint [1] 263251 0
At time of intervention procedure.
Secondary outcome [2] 263252 0
Successful cannulation (blood return) of AV fistula through the Venous Window Needle Guide with sharp fistulae needle.
Timepoint [2] 263252 0
3 - 5 weeks post intervention
Secondary outcome [3] 263253 0
Successful cannulation (blood return) of AV fistula through Venous Window Needle Guide with blunt fistula needle.
Timepoint [3] 263253 0
Within 3 months post intervention

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
11/06/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
7
Accrual to date
Final
Recruitment outside Australia
Country [1] 2493 0
New Zealand
State/province [1] 2493 0

Funding & Sponsors
Funding source category [1] 256514 0
Commercial sector/Industry
Name [1] 256514 0
Vital Access, Corp.
Country [1] 256514 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Vital Access, Corp.
Address
2302 South Presidents Drive, Suite C
Salt Lake City, Utah 84120
Country
United States of America
Secondary sponsor category [1] 255823 0
None
Name [1] 255823 0
Address [1] 255823 0
Country [1] 255823 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 258559 0
Ethics committee address [1] 258559 0
Ethics committee country [1] 258559 0
Date submitted for ethics approval [1] 258559 0
19/02/2010
Approval date [1] 258559 0
Ethics approval number [1] 258559 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30837 0
Address 30837 0
Country 30837 0
Phone 30837 0
Fax 30837 0
Email 30837 0
Contact person for public queries
Name 14084 0
Mark Crawford
Address 14084 0
2302 South Presidents Drive, Suite C
Salt Lake City, Utah 84120
Country 14084 0
United States of America
Phone 14084 0
+1 801-433-9390
Fax 14084 0
+1 801-433-9391
Email 14084 0
[email protected]
Contact person for scientific queries
Name 5012 0
Mark Crawford
Address 5012 0
2302 South Presidents Drive, Suite C
Salt Lake City, Utah 84120
Country 5012 0
United States of America
Phone 5012 0
+1 801-433-9390
Fax 5012 0
+1 801-433-9391
Email 5012 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.