NCT07548151已完成不适用
Ultrasound-Guided Power-Assisted Needle Insertion for Vascular Access Study
X9, Inc.1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年4月14日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
研究概览
简要总结
The goal of this clinical trial is to determine whether the study device can assist the cannulator with placing two needles during cannulation required to initiate dialysis treatment.
Males or females with end-stage kidney disease who are 18 and older and not pregnant or breastfeeding can be included in the study.
The main question it aims to answer is:
Can the study device guide the cannulator to the arteriovenous fistula (AVF) or arteriovenous graft (AVG) and assist the cannulator with needle insertion into the AVF or AVG for dialysis cannulation?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
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
- •Males or non-pregnant, non-breastfeeding females ≥ 18 years of age
- •Presence of an AVG/AVF access site in the forearm or upper arm
- •AVF is actively used for dialysis treatment
- •AVF diameter is between 8 mm and 12mm, confirmed by ultrasound
- •AVF is ≤6 mm below the surface of the skin, confirmed by ultrasound
- •Able to report their pain using a validated pain scale.
- •Able and willing to provide written informed consent.
排除标准
- •Presence of known (pseudo-)aneurysms, stenosis, thrombosis or stents in the AVF/AVG access site
- •Presence of a condition or impediment that may interfere with ultrasound imaging
研究者
研究点 (1)
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