NCT04526301Unknown不适用
Home With TablO outcoMEs (HOME) Registry
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 10
- 主要终点
- Weekly Standardized Dialysis Adequacy
研究概览
简要总结
Prospective, multicenter, single arm, post-market study to evaluate real world clinical outcomes in ESRD patients receiving in-home dialysis on the Tablo Hemodialysis System.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant (patient and/or care partner) is at least 15 years of age and has provided informed consent and has signed a Health Insurance Portability and Accountability Act of 1996 (HIPAA) compliant authorization statement.
- •Participant weighs ≥ 34kg.
- •Participant has end stage renal disease (ESRD) adequately treated by maintenance dialysis.
- •Participant plans to start or has started home treatment (≤ 6 months) with the Tablo Hemodialysis System.
- •Participant is willing and able to comply with the Protocol requirements and perform all site required treatments and clinical evaluations.
排除标准
- •Participant and/or care partner is unable to read English or Spanish.
- •Participant has a home environment that is deemed inappropriate for home dialysis.
- •Participant and/or care partner is unable to successfully complete the Tablo training program
- •Participant is pregnant or plans to become pregnant.
结局指标
主要结局
Weekly Standardized Dialysis Adequacy
时间窗: 12-months
Weekly standardized dialysis adequacy (stdKt/V) measured using the second-generation formula of Daugirdas. This formula normalizes urea clearance among heterogeneous hemodialysis schedules, where K=dialyzer clearance or urea, t=treatment time, and V=subject's volume of urea distribution. stdKt/V values of ≥ 2.1 are regarded as being adequate.
次要结局
未报告次要终点
研究者
研究点 (10)
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