跳至主要内容
临床试验/NCT03256383
NCT03256383Unknown不适用

Plan for Testing Fingerstick Bloods on Magellan Systems

Magellan Diagnostics2 个研究点 分布在 1 个国家目标入组 190 人开始时间: 2017年7月31日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
190
试验地点
2
主要终点
Lead poisoning

研究概览

简要总结

This study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on Magellan's lead testing systems: LeadCare II, LeadCare Ultra (which have been cleared previously by FDA), and PediaStat, which is an upgraded LeadCare II instrument in development.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

性别
All
接受健康志愿者
是

入选标准

  • •healthy subjects who consent to a capillary blood collection

排除标准

  • •Patients are not currently taking chelating agents, e.g., penicillamine, succimer

结局指标

主要结局

Lead poisoning

时间窗: 1 day

\>10ug/dL lead in whole blood is considered lead poisoning These measurements will be taken to compare the fingerstick data collected in the field with data received through reference method

次要结局

未报告次要终点

研究者

发起方
Magellan Diagnostics
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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