NCT01921452已完成4 期
A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 283
- 试验地点
- 1
- 主要终点
- Concentration of TSH in Whole Blood
研究概览
简要总结
This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected hypothyroidism subject
- •Willing to comply with the trial protocol
- •Signed informed consent document
排除标准
- •Menstrual period, bleeding hemorrhoids, hematuria
- •Drinking or taking aspirin within 48 hours
- •Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
- •Subjects who are unwilling or unable to complete the trial
- •Subjects who do not sign informed consent form
结局指标
主要结局
Concentration of TSH in Whole Blood
时间窗: Day 1 up to Day 5
Number of Participants With Positive and Negative TSH Test Result
时间窗: Day 1 up to Day 5
次要结局
未报告次要终点
研究者
研究点 (1)
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