PheCheck Feasibility Study

Status Recruiting

Clinical Trial Summary

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

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Phenylketonurias

Clinical Trial Details

NCT number	NCT05998109
Study type	Observational
Source	Lumos Diagnostics
Contact	Catalina Suarez-Cuervo, MD
Phone	7277765880
Email	Catalina.Suarez@lumosdiagnostics.com
Status	Recruiting
Phase
Start date	September 5, 2023
Completion date	March 15, 2024

View Details

See also
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