Automated 3D Ultrasound-based Surveillance of Arteriovenous Fistula Maturation for Post-operative Hemodialysis Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Safety Endpoint
研究概览
简要总结
This is a two stage, prospective, multi-center study to evaluate the EchoMark and EchoSure devices in patients undergoing peripheral arteriovenous fistula creation for hemodialysis access.
详细描述
This is Stage 1 of a 2 stage protocol, targeting to enroll 60 patients in prospective, single arm, non-randomized, multi-center observational study to record objective data in patients undergoing upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access, in whom the EchoMark is placed at the site of vascular anastomosis. Follow-up visits include EchoSure and duplex imaging.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Patients presenting for upper extremity arteriovenous fistula construction with autologous tissue for the purpose of eventual hemodialysis access where the surgeon has selected EchoMark and EchoSure as the optimal method of vascular monitoring based on clinical assessment and plan
- •Patient is able to sign informed consent and able to participate in all testing associated with this clinical investigation
- •Women of childbearing potential have a negative pregnancy test
排除标准
- •Age <18 years old
- •Patient unable to sign informed consent
- •Patient participating in another investigational device or pharmacological study
- •Prisoner or patient from vulnerable populations as defined in 45 CFR 46.
结局指标
主要结局
Safety Endpoint
时间窗: 24 Weeks
Number of Subjects with Freedom from Serious Adverse Events (SAEs) during the EchoMark implantation procedure and sub-sequent post-operative period.
Performance: Data Collection
时间窗: 24 weeks
Data collection to verify accuracy
Performance Endpoint
时间窗: 24 Weeks
Data collection to understand the natural history of flow physiology in AV fistulas and classify the fistula that will fail.
次要结局
未报告次要终点