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 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.
Interventions
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
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.
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 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.
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.
Outcome results
None listed