ACTRN12618001797268已完成未知
on-randomized safety and performance evaluation of the av-Guardian Vascular Access System for deep fistula and for use by self-cannulating patients.
Advent Access Pte Ltd0 个研究点目标入组 6 人开始时间: 2018年11月5日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 21 Years 至 75 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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 AVFinvolving 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.
研究者
相似试验
已完成
不适用
Safety and performance evaluation of the av-Guardian Vascular Access System for hemodialysis patientsvascular access to arterio-venous fistula (AVF) for hemodialysisRenal and Urogenital - Kidney diseasechronic kidney diseaseACTRN12617000501347Advent Access Pte Ltd6
未知
不适用
The investigation of the safety and efficiency of desk work using automatic wheel chair with assistance for standing in the person with a disability of lower extremityPerson with a disability of lower extremityJPRN-UMIN000023678Tottori University Hospital10
尚未招募
不适用
A comparative study of effectiveness of Alpha2 agonist (Dexmedetomidine) versus opioid (fentanyl) for awake intubation using flexible bronchoscopeCTRI/2022/03/041196Vinayaka missions kirupanda variyar medical college and hospital
进行中（未招募）
不适用
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.Opioid dependanceMedDRA version: 9.1Level: LLTClassification code 10013663Term: Drug dependenceEUCTR2006-005234-21-SISchering-Plough Research Institute240
进行中（未招募）
不适用
A Randomized Acceptability and Safety Study of the Transfer From Subutex to Suboxone in Opioid-Dependent Subjects.EUCTR2006-005234-21-SESchering-Plough Research Institute240