PheCheck Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
研究概览
简要总结
The goal of this feasibility study clinical trial is to compare the accuracy of PheCheck™ for the rapid quantitative detection of phenylalanine (Phe) with the gold standard (HPLC amino acid analyzer), in patients with PKU.
The main aims are:
- Evaluate the accuracy of PheCheck as compared to the gold standard
- Evaluate ease of use by lay participants
详细描述
The primary objective of this feasibility study is to evaluate the accuracy of the analyte concentration of PheCheck™ for the rapid, quantitative detection of phenylalanine (Phe) from capillary blood compared to the gold standard (HPLC amino acid analyzer) which quantitatively measures Phe in venous blood.
The study will enroll subjects into one study cohort. It will include patients 10 years or older, monitored for Phenylketonuria (PKU), hyperphenylalaninemia or PKU during pregnancy.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •10 years of age or older
- •Being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy Signed informed consent
排除标准
- •Younger than 10 years of age
- •Not being monitored for Phenylketonuria (PKU), hyperphenylalaninemia or for PKU during pregnancy
- •Lack of signed informed consent
- •Previous enrollment in the study and has completed study visit 1 and 2
结局指标
主要结局
Concentration of phenylalanine (Phe) from PheCheck as compared to HPLC amino acid analyzer
时间窗: 6-8 weeks
The primary outcome is the concentration of phenylalanine (Phe) from capillary blood as compared to the gold standard HPLC amino acid analyzer
次要结局
未报告次要终点