The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12618001797268
Ethics application status
Approved
Date submitted
8/10/2018
Date registered
5/11/2018
Date last updated
24/04/2020
Date data sharing statement initially provided
5/11/2018
Date results information initially provided
24/01/2020
Type of registration
Retrospectively registered

Titles & IDs
Public title
Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patients, including patients with deep AV- fistulas and self-cannulating patients
Scientific title
Non-randomized safety and performance evaluation of the av-Guardian Vascular Access System for deep fistula and for use by self-cannulating patients.
Secondary ID [1] 294788 0
NONE
Universal Trial Number (UTN)
U1111-1213-3691
Trial acronym
Linked study record
ACTRN12617000501347

This previous record is a sub-study of this study

Health condition
Health condition(s) or problem(s) studied:
vascular access to arterio-venous fistula (AVF) for hemodialysis 307787 0
chronic kidney disease 307788 0
Condition category
Condition code
Renal and Urogenital 306833 306833 0 0
Kidney disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The av-Guardian device is a small medical grade titatnium 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 for the implantation. 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 - In Center] 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. Once vascular access with the sharp needle has been consistent for 6-10 sessions, a blunt needle can be used. The renal nurse will continue cannulation for the subject until at least 6 consecutive blunt needling sessions has been achieved, after which the subject will need to perform at least 3 sessions of self-cannulation successfully with the blunt needle before being evaluated by the renal nurse and principal investigator for suitability to return home for the rest of the study.
[Cannulation Phase - Home] Patients returning home to complete the rest of the trial are trained by the renal nurse and provided with self-needling guide and the patient diary (for clinical trial). Training in self-cannulation comprises of a minimum of 3 sessions of hands-on practice by the patient in-centre, supervised and guided by the renal nurse. After the patient returns home, renal nurses will check on the cannulation status of the home dialyzing patients every session for the 3 sessions, then once every 3 sessions in the first month, and at least once every 5 sessions in the subsequent months until the end of the trial.
(total of 40 cannulation phase dialysis sessions)
[Long-term Follow-up Observational Phase] Upon completion of the 40 sessions post first cannulation follow up (completed study endpoints), all subjects are entitled to continue using the av-Guardian device at their original dialysis centres or on returning to their home dialysis, as per their hemodialysis routine prior to joining the trial. They will also be asked if they are agreeable to continue providing data on device safety and performance
Intervention code [1] 301153 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 305828 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, by patient's dialysis parameters of venous pressures and dialysis machine flow rate, and by ultrasound scan.
Timepoint [1] 305828 0
Baseline, and within 1 week post-implantation
Primary outcome [2] 305829 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] 305829 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 about 4.5 months after first cannulation through the device (Follow-up cannulation phase),
Primary outcome [3] 305830 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] 305830 0
At cannulation 3 times a week for about 4.5 months after first cannulation through the device (Follow-up cannulation phase)
Secondary outcome [1] 346692 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] 346692 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] 346693 0
av-Guardian aids in the self-cannulation by patients, as determined by the timepoint at which patient is able to perform self-cannulation with the blunt needle for the first time, by direct observation by a research nurse at each cannulation.
Timepoint [2] 346693 0
Assessed at cannulation 3 times a week until patient is able to self-cannulate for the first time.
Secondary outcome [3] 346694 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 [3] 346694 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 3.5mm and 10mm under the skin.
d. With minimum diameter of >= 5mm at cannulation segment.
4. 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
Gender
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 with active systemic infection.
5. Subjects on immunosuppression medication.
6. Subjects with non-treated malignant disease.
7. Subjects with pre-existing allergies such as titanium allergy or known allergy to any component part of the investigational device.
8. Subjects with skin anomalies such as skin infections, skin disorders, hypersensitive skin at the potential target implantation site.
9. Subjects who have a topical or active subcutaneous infection associated with the implantation site.
10. Subjects who have local tissue factors that will prevent proper device stabilisation or access.
11. Subjects with uncontrolled diabetes mellitus defined as HbA1c of = 10% or its equivalent, for a duration of at least 1 year.
12. Subjects with uncontrolled coagulation disorders.
13. Subjects determined to be an unsuitable candidate for self- cannulation.

AVF Related Exclusion
14. Subjects who underwent a surgical revision on the target AVF involving placement of a prosthetic graft.
15. Subjects with history of more than two intervention per year on the target AV-fistula.
16. Subjects with recent intervention on the target AV-fistula < 3 months.
17. Subjects are unable to complete at least one dialysis session at the chosen implant site cannulation segment.

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 3-4 cannulations per week for 40 dialysis sessions, with each device. This results in a total of 80 cannulations per subject. The assessments made on these calculations are of a repeated nature, as there will be multiple assessments both per subject and per device. No account has been taken of this in the calculation of the estimates of precision which follow.
Lead-in subject will be included in the analysis of safety endpoints, but excluded from the analysis for performance endpoints.
Assuming a 100% (7/7) procedural success rate (i.e. <30% reduction in access blood flow rate and no damage to AVF), it is estimated (using the Wilson method) that the 95% confidence interval on the rate will be 64.5% - 100.0%. There will also be 560 (7x2x40) cannulations available for analysis. Assuming a 75% cannulation success rate (420/560), the 95% confidence interval on the cannulation success rate will be 70.9% - 78.7%.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 10388 0
New Zealand
State/province [1] 10388 0
Hamilton

Funding & Sponsors
Funding source category [1] 299396 0
Commercial sector/Industry
Name [1] 299396 0
Advent Access Pte Ltd
Address [1] 299396 0
1 Lorong 2 Toa Payoh
#07-00 Braddell House
Singapore 319637
Country [1] 299396 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] 298679 0
None
Name [1] 298679 0
Address [1] 298679 0
Country [1] 298679 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300299 0
Southern Health and Disability Ethics Committee
Ethics committee address [1] 300299 0
133 Molesworth Street
Thorndon
Wellington 6011
Ethics committee country [1] 300299 0
New Zealand
Date submitted for ethics approval [1] 300299 0
12/12/2016
Approval date [1] 300299 0
05/04/2017
Ethics approval number [1] 300299 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 with a device guided constant site technique- this method predicate on the buttonhole technique. The av-Guardian guides the needle during 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. After needle tract formation, the patient may continue to use the device to aid in self- cannulation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83202 0
Mr Thodur Vasudevan
Address 83202 0
Clinical Trials New Zealand
32 Kahikatea Drive
Hamilton, 3206
New Zealand
Country 83202 0
New Zealand
Phone 83202 0
+64 78 430 105
Fax 83202 0
Email 83202 0
vasudevt@clinicaltrialsnz.com
Contact person for public queries
Name 83203 0
Dr Ivon Septriyana
Address 83203 0
MD- Clinicals
Route de Deng es 28C
1027 Lonay, Switzerlan d
Country 83203 0
Switzerland
Phone 83203 0
+41 21 349 9626
Fax 83203 0
Email 83203 0
iseptriyana@md-clinicals.com
Contact person for scientific queries
Name 83204 0
Mr Thodur Vasudevan
Address 83204 0
Clinical Trials New Zealand
32 Kahikatea Drive
Hamilton, 3206
New Zealand
Country 83204 0
New Zealand
Phone 83204 0
+64 78 430 105
Fax 83204 0
Email 83204 0
vasudevt@clinicaltrialsnz.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
data collected will only be used internally by the company. A summary of the analysed results may be available at a later time.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary