on-randomized safety and performance evaluation of the av-Guardian Vascular Access System in 6 chronic hemodialysis patients

Advent Access Pte Ltd0 个研究点目标入组 6 人开始时间: 2017年4月6日最近更新: 2020年5月4日

适应症

试验速览

暂无简介。

•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.

•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.

发起方

Advent Access Pte Ltd