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Trial registered on ANZCTR


Registration number
ACTRN12617000501347
Ethics application status
Approved
Date submitted
19/01/2017
Date registered
6/04/2017
Date last updated
24/04/2020
Date data sharing statement initially provided
11/04/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patients
Scientific title
Non-randomized safety and performance evaluation of the av-Guardian Vascular Access System in 6 chronic hemodialysis patients
Secondary ID [1] 290934 0
NONE
Universal Trial Number (UTN)
U1111-1190-4319
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
vascular access to arterio-venous fistula (AVF) for hemodialysis 301656 0
chronic kidney disease 302740 0
Condition category
Condition code
Renal and Urogenital 301365 301365 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The av-Guardian device is a small medical grade titanium implant, which will be implanted in the subcutaneous space above the fistula and under the skin by a vascular surgeon. [Procedure phase] Implantation of the device will be performed using the deployment tool, a spoon-like instrument on which the av-Guardian device sits and is used to deliver the device into the subcutaneous space through a small incision. Two devices will be implanted per patient, one at the arterio side of the fistula (A site for suction of blood into the dialysis machine), and the other at the venous side (V site for return of blood from the dialysis machine). The procedure is minimally invasive, will take about 10 min. It will be done in the operating theatre.
[Healing Phase] 2-4 weeks post-implantation, the implanting vascular surgeon will check the implant for sufficient fibrosis and stability, to determine device readiness for cannulation.
[Cannulation Phase] After determination of device readiness by the vascular surgeon, the device will be used by trained cannulators such as renal nurses, nephrologist, interventionalist to guide the fistula needle for access to the AVF for hemodialysis, using a method that is similar to the buttonhole cannulation technique. Patients will be observed for cannulation through the device 3x a week, for 3 months from the first cannulation through the device. (total of 36 cannulations). Cannulation will be done at the designated trial dialysis centre.
[Long-term Follow-up Observational Phase] Upon completion of the 3 months post first cannulation follow-up, patients are entitled to continue using the device at their original dialysis centre, as they return to their routine dialysis treatment (pre-trial). They will also be asked if they are agreeable to continue providing data on device safety and performance.
The device can remain in situ for the lifetime of the fistula.
Intervention code [1] 296872 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 300759 0
Safety of the implantation procedure, as determined by the change in access blood flow rate in the AVF from pre- to post- implantation, measured by transonic flow rate or ultrasound.
Timepoint [1] 300759 0
Baseline, and Immediately post-implantation
Primary outcome [2] 300760 0
Safety of the device, as determined by the rate of successful hemodialysis session with or without cannulation using the av-Guardian through the target AVF by direct observation by a research nurse at the end of the dialysis session.
Timepoint [2] 300760 0
Post dialysis 3 times a week for about 3 weeks (up to a month) before cannulation through the device (Follow-up healing phase); and post dialysis 3 times a week for 3 months after first cannulation through the device (Follow-up cannulation phase),
Primary outcome [3] 300798 0
Successful cannulation of the AVF through the av-Guardian, as determined by the rate of successful vascular access allowing dialysis through the av-Guardian device by direct observation by a research nurse at each cannulation. .
Timepoint [3] 300798 0
At cannulation 3 times a week for 3 months after first cannulation through the device (Follow-up cannulation phase).
Secondary outcome [1] 330808 0
av-Guardian aids in the successful creation of a needle track, as determined by the timepoint at which blunt needle puncture is reached by direct observation by a research nurse at each cannulation. .

Timepoint [1] 330808 0
Assessed at cannulation 3 times a week until the a needle track is observed and a blunt needle is used successfully for the cannulation.
Secondary outcome [2] 345299 0
Monitoring of safety and effectiveness beyond study endpoints, as determined by observation of device related adverse events and, cannulation success and dialysis up to 36 months follow-up post first cannulation through the device.
Timepoint [2] 345299 0
Assessed at cannulation 3 times a week during dialysis, and for up to 36 months follow-up post first cannulation through the device.

Eligibility
Key inclusion criteria
1. Subjects who are able to provide a written informed consent prior to participating in the clinical investigation.
2. Established chronic haemodialysis subjects.
3. Subjects with an established AVF that is:
a. Successfully in use for >= 12 dialysis sessions.
b. With a flow of > 600 cc/min (if the flow is <= 600 cc/min, an approval from the sponsor’s medical representative is mandatory).
c. Located between 4mm and 8mm under the skin.
d. With minimum diameter of >= 5mm at cannulation segment.
e. Subjects with an estimated life expectancy of >= 1 year from the date of signature on the informed consent.
Minimum age
21 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subjects who are not able to comply with the clinical investigation follow-up or other clinical investigation requirements.
2. Subjects involved concurrently in another drug or device clinical investigation that may potentially clinically interfere with the endpoints of this clinical investigation.
3. Subjects who are pregnant or intend to become pregnant during the duration of the clinical investigation.
4. Subjects who underwent a surgical revision on the target AVF involving placement of a prosthetic graft.
5. Subjects with active systemic infection.
6. Subjects on immunosuppression medication.
7. Subjects with non-treated malignant disease.
8. Subjects with valvular heart disease.
9. Subjects with pre-existing allergies such as titanium allergy or known allergy to any component part of the investigational device.
10. Subjects with skin anomalies such as skin infections, skin disorders, hypersensitive skin at the potential target implantation site.
11. Subjects with uncontrolled diabetes mellitus
12. Subjects with uncontrolled coagulation disorders.
13. Obese subjects (BMI > 35).
14. Subjects with history of more than one intervention per year on the target AV-fistula.
15. Subjects with recent intervention on the target AV-fistula < 6 months.

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
Each subject will receive 2 devices and undergo 3 cannulations per week for 3 months with each device, resulting in a total of 36 cannulations per device, and 72 cannulations per subject. Assuming a 100% (12/12) procedural success rate, it is estimated (using the Wilson method) that the 95% confidence interval on the rate will be 75.7% - 100.0%. There will also be 432 (6x2x36) cannulations available for analysis. Assuming a 75% cannulation success rate (324/432), the 95% confidence interval on the cannulation success rate will be 70.7% - 78.9%. These estimates are considered to be sufficiently precise.

The endpoints will by evaluated by subject and by device. Specific to the endpoint being analysed, the subject and/or the device will be included as a repeated effect in the analysis.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
28/03/2016
Date of last participant enrolment
Anticipated
30/04/2017
Actual
17/01/2017
Date of last data collection
Anticipated
13/07/2020
Actual
20/04/2020
Sample size
Target
6
Accrual to date
Final
6
Recruitment outside Australia
Country [1] 8591 0
Singapore
State/province [1] 8591 0
Singapore
Country [2] 8592 0
New Zealand
State/province [2] 8592 0
Hamilton

Funding & Sponsors
Funding source category [1] 295352 0
Commercial sector/Industry
Name [1] 295352 0
Advent Access Pte Ltd
Country [1] 295352 0
Singapore
Primary sponsor type
Commercial sector/Industry
Name
Advent Access Pte Ltd
Address
1 Lorong 2 Toa Payoh
#07-00
Braddell House
Singapore 319637
Country
Singapore
Secondary sponsor category [1] 294176 0
None
Name [1] 294176 0
Address [1] 294176 0
Country [1] 294176 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296684 0
Singhealth Centralised Instituitional Review Board
Ethics committee address [1] 296684 0
31 Third Hospital Avenue
#03-03 Bowyer Block C
Singapore 168753
Ethics committee country [1] 296684 0
Singapore
Date submitted for ethics approval [1] 296684 0
Approval date [1] 296684 0
14/10/2015
Ethics approval number [1] 296684 0
2015/2685
Ethics committee name [2] 296714 0
Southern Health and Disability Ethics Committee
Ethics committee address [2] 296714 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [2] 296714 0
New Zealand
Date submitted for ethics approval [2] 296714 0
12/12/2016
Approval date [2] 296714 0
05/04/2017
Ethics approval number [2] 296714 0
16/STH/249

Summary
Brief summary
The purpose of the study is to assess the safety and performance of the av-Guardian
Vascular Access System, The av-Guardian is designed to aid in a repeatable and reliable vascular access to the AVF for patients undergoing chronic hemodialysis, using a constant site method of needle insertion.
Current techniques for cannulation to access an AVF for dialysis are:
1. rope ladder technique: involves cannulation of the whole access length, alternate cannulation points spaced 3cm apart; however, if 3cm spacing is not available, cannulator tends to space cannulation points within millimeters apart, resulting in area cannulation
2. Area technique: involves cannulation in the same small vessel area, which may lead to vessel damage and the development of stenosis and aneurysm
3. Buttonhole technique: involves constant cannulation on the same spot for all dialysis sessions (which requires the same skilled nurse to cannulate the patient at the exact same spot, at the exact same angle, at the exact same depth, for 10-20 sessions). A sharp needle is first used in the access, but as a scar tissue tract develops, a blunt needle can be used to access the AVF, which may be less painful for the patient.
Despite the advantage in delaying interventions and reducing the number of common complications associated with AVF, the Buttonhole technique is not widely used due to the high skill barrier. Participants in the study will be cannulated using a method that is similar to the buttonhole technique- predicating on the buttonhole technique, the av-Guardian guides the cannulation, lowering the skill variability required in the creation and maintenance of a quality needle tract, so that the benefits of the buttonhole technique can be achieved.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71770 0
A/Prof Lina Choong
Address 71770 0
The Academia - Singapore General Hospital,
20 College Road
Level 3
Singapore 169856
Country 71770 0
Singapore
Phone 71770 0
+65 6321-4436
Fax 71770 0
Email 71770 0
[email protected]
Contact person for public queries
Name 71771 0
Ivon Septriyana
Address 71771 0
MD- Clinicals
Route de Denges 28C
1027 Lonay, Switzerland
Country 71771 0
Switzerland
Phone 71771 0
+41 21 349 9626
Fax 71771 0
Email 71771 0
[email protected]
Contact person for scientific queries
Name 71772 0
Lina Choong
Address 71772 0
The Academia - Singapore General Hospital,
20 College Road
Level 3
Singapore 169856
Country 71772 0
Singapore
Phone 71772 0
+65 6321-4436
Fax 71772 0
Email 71772 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
only results summary will be made available through a publication.


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
SourceTitleYear of PublicationDOI
EmbaseNon-randomized safety and performance evaluation of the av-Guardian vascular access system.2020https://dx.doi.org/10.1177/1129729819898306
N.B. These documents automatically identified may not have been verified by the study sponsor.