NCT04198012已完成不适用
An Open Label Study to Allow Patients Continuous Use of the HemoCare™ Hemodialysis System for Home Hemodialysis Prior to Market Authorization
Deka Research and Development13 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2019年12月16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
- 25
- 试验地点
- 13
- 主要终点
- Number of Subjects With Safety Event
研究概览
简要总结
This study is designed to monitor and assess the safety of continued access to the HemoCare™ Hemodialysis System used during the review of the pre-market notifications for the devices in the HemoCare™ Hemodialysis 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
- 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
- •Completed DEKA Protocol DKPL 00057 001 and are qualified to enter the study based on the assessment of the Investigator.
- •Are willing to comply and capable of complying with the study requirements for therapy with the HemoCare™ Hemodialysis System.
- •Have a trained study care partner able to support subject for all at-home study treatments.
- •Subject and care partner can read and understand English and provide written informed consent.
- •Have a stable functioning vascular access as judged by the treating physician.
排除标准
- •Have a current self-reported pregnancy or are actively planning to become pregnant within the next 12 months, lactating, or not using medically acceptable means of contraception during the study.
- •Have any any other clinically significant medical disease or condition or subject responsibility that, in the Investigator's opinion, may interfere with a subject's (and/or care partner's) ability to give informed consent, adhere to the protocol, interfere with assessment of the investigational product (IP), or serve as a contraindication to the subject's participation in the study.
- •Have a significant psychiatric disorder or mental disability that could interfere with the subject's ability to provide informed consent and/or comply with study procedures.
- •Are participating or planning to participate in any other interventional studies except DKPL-00057-001.
结局指标
主要结局
Number of Subjects With Safety Event
时间窗: 52 weeks
The Total Number of subjects having at least one Anticipated AE, Unanticipated AE, Device Related AE, Anticipated SAE, Unanticipated SAE and Device Related SAEs.
次要结局
未报告次要终点
研究者
研究点 (13)
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