None listed
Conditions
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.
Interventions
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
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
Sponsors
Advent Access Pte Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
21 Years to 75 Years
Healthy volunteers
No
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.
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.
Outcome results
None listed