NCT06056739招募中不适用
Alio WEAR Study: Long-term Wear of the Alio Platform
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Alio, Inc.
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Assessing usage of the Alio platform by the test subject
研究概览
简要总结
The WEAR study is long-term interventional study designed to evaluate patient and clinician use of the Alio platform, per its FDA cleared indications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 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
- •At least 18 years of age.
- •Receiving hemodialysis via an AVF or AVG in an arm location at the time of study start.
- •Able to wear the SmartPatch effectively at the specified location on the arm.
- •Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of any study procedures.
- •Willing and able to wear the SmartPatch as instructed and comply with all interviews, surveys and questionnaires, and schedule of evaluations.
排除标准
- •Skin near the proximity of the AV access that is chronically swollen, infected, inflamed, open wounds, lesions, or has skin eruptions.
- •Participation in any other clinical trials involving investigational or marketed products that in the opinion of the investigator could affect the quality of the data.
- •Other conditions that in the opinion of the Principal Investigator may increase risk to the subject and/or compromise the quality of the clinical trial.
结局指标
主要结局
Assessing usage of the Alio platform by the test subject
时间窗: Up to 1 year
Assessing compliance and ease of use via surveys
次要结局
未报告次要终点
研究者
研究点 (2)
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