NCT06691672已完成不适用
Feasibility Study of Dialysis Clinic Semi-Autonomous Ultrasound Scanning Using the Vexev Ultrasound Imaging System for Arteriovenous Fistula Mapping Examinations.
Vexev Pty Ltd2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2024年11月20日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability
研究概览
简要总结
Study to assess the feasibility of dialysis clinic staff to perform upper limb mapping ultrasound scans using the Vexev Ultrasound Imaging System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Referred to a study site for chronic renal replacement therapy OR referred to a study site for management of CKD.
- •Able to understand the procedures and requirements of the study and provide written informed consent and authorization for protected health information disclosure.
- •Greater than or equal to 21 years of age at the time of written informed consent.
排除标准
- •Patients' unable to load arm into scanning bed (due to upper limb medical co-morbidities/injury).
- •Patient has evidence of open or incompletely healed wounds on both arms. Patients with open or incompletely healed wounds on a single arm are not excluded - if the ipsilateral arm is not able to be scanned - contralateral arm may be scanned.
- •Any acute or chronic condition that would limit the ability of the patient to participate in the study - in the opinion of the principal investigator.
- •Previous vascular/vascular access surgery on both upper limbs. Patients with previous vascular/vascular access surgery on a single arm are not excluded- contralateral arm may be scanned.
结局指标
主要结局
Vascular Access Robotic Tomographic Ultrasound (RTU) Mapping Efficacy and Feasability
时间窗: From enrollment to the end of viable assessment window at 90 days.
The proportion of RTU vascular mapping scans performed using the VxWave Vascular Ultrasound Imaging Device that are assessed by interventionalists to provide sufficient imaging data to determine vascular access options.
次要结局
未报告次要终点
研究者
研究点 (2)
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