NCT07599085尚未招募不适用
Early Feasibility Study to Assess the Safety and Effectiveness of the OnePoint Dialysis CannulaTM as a Single-Site Vascular Access Device for Hemodialysis Procedures
Evolve Medicus, Inc.0 个研究点目标入组 20 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 主要终点
- Dialysis Cannulation Data CRF
研究概览
简要总结
This is an early feasibility, pre-market, prospective, interventional, single-arm, non-randomized / open-label study intended to support a future pivotal IDE study for eventual FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Subject is an adult patient ≥ 18 years of age.
- •Subject with the ability to attend "in-center" hemodialysis.
- •Subject has a requirement of hemodialysis 3 times/week.
- •Subject has an AVF that was determined to be mature by standard clinical definition
- •Subject with ≥ 3 months stable in center hemodialysis with >90 days use of an AV fistula cannulated with 2 needles with no evidence of stenosis or thrombosis.
- •Subject has an AVF that meets all of the following Rule of 5s:
- •Flow ≥ 500 mL/min
- •Diameter ≥ 5 mm
- •Depth ≤ 5 mm from the skin surface
- •Length ≥ 5 cm usable for cannulation
- •Subject does not have any established lesions or stents in the access circuit as confirmed by ultrasound.
- •Subject dialyzes at a center that can confirm 30-day data collection on cannulations and is willing to cooperate in performing real-time assessments and record keeping per Sponsor requirements, to assure subject safety requirements.
排除标准
- •Subject has an existing arteriovenous graft.
- •Subject has any active infection within the past 90 days.
- •Subject is currently receiving or planning home hemodialysis.
- •Subject has a distorted anatomy and/or local vascular injury.
- •Subject has a change in blood thinner regimen in the last 60 days.
- •Subject has any unstable medical or psychiatric conditions likely to impair their ability to participate in the study.
- •Subject has a known history of clinically significant IV drug use.
- •Subject is a pregnant or nursing woman, or anticipates pregnancy in the next 3 months.
- •Subject is enrolled in another study that could confound the results of this study, without documented pre-approval.
- •Subject has a known allergy to plastics.
- •Subject is unwilling to sign the study's consent form.
- •Subject has a life expectancy of less than 12 months.
研究组 & 干预措施
OnePoint Dialysis Cannula
Experimental
Single-site vascular access device intended to be used in patients receiving hemodialysis
干预措施: OnePoint Dialysis Cannula (Device)
结局指标
主要结局
Dialysis Cannulation Data CRF
时间窗: 30 days
Percentage of attempted device cannulations that successfully result in completion of the prescribed hemodialysis treatment sessions over a 30-day period.
次要结局
未报告次要终点
研究者
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