跳至主要内容
临床试验/NCT00579202
NCT00579202已完成不适用

The Gambro Polyflux HD-C4 Small Ease of Use Study

Vantive Health LLC1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2007年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
24
试验地点
1
主要终点
For each dialyzer, the perceived ease of priming.

研究概览

简要总结

The purpose of the study is to study the ease of use of the Polyflux HD-C4 Small dialyzer under conditions of routine clinical use for hemodialysis

详细描述

Market evaluation protocol.

This ease of use study involves the use of FDA 510(k) cleared hemodialyzers and will have no impact on the patient's routine dialysis therapy. This study is strictly aimed at obtaining feedback from the nursing and technical staff regarding the use of the Polyflux HD-C4 Small dialyzer. The dialysis nursing staff will complete ease of use assessments following routine dialysis therapy.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • n/a routine dialysis patients

排除标准

  • n/a routine dialysis patients

结局指标

主要结局

For each dialyzer, the perceived ease of priming.

时间窗: During priming of each dialyzer

次要结局

  • Visual assessment of residual blood in the dialyzer after rinse-back and if dialyzer clotted during treatment.(At the completion of each treatment)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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